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| Product NDC Code | 41167-0039 | ||||||||||
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| Drug Name | Cortizone 10 |
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| Type | Brand | ||||||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | CREAM | ||||||||||
| RxCUI drug identifier | 106258, 198706, 203105, 206314, 206352, 846161 |
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| Application Number | M017 | ||||||||||
| Labeler Name | Chattem, Inc. | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient : Hydrocortisone 1%
Active Ingredient: Hydrocortisone 1%
Active Ingredient: Hydrocortisone 1%
Active Ingredient: Hydrocortisone 1%
Active Ingredient: Hydrocortisone 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive I ngredients aloe barbadensis leaf juice, avena sativa (oat) kernel extract, cyclopentasiloxane, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate 60, propylparaben, SD Alcohol 40-2 (15%), sodium citrate, water CHATTEM® *Refers to the ingredient hydrocortisone Distributed by CHATTEM, INC. P.O. Box 2219, Chattanooga, TN 37409-0219 USA ©2008 www.ditchtheitch.com 0042740-02 Cortizone-10 ® Crem e
Inactive Ingredients aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water *Refers to the ingredient hydrocortisone CHATTEM® Distributed by CHATTEM, INC. P.O. Box 2219, Chattanooga,TN 37409-0219 USA ©2008 www.chattem.com 0040433-02 Minor change Cortizone-10 ® Cre me Intensive Healing Formula
Inactive Ingredients water, glycerin, dimethicone, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-21, steareth-2, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, methyl gluceth-20, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, hydrolyzed collagen, hydrolyzed elastin, retinyl palmitate, hydrolyzed jojoba esters, glyceryl stearate, EDTA, PPG-12/SMDI copolymer, potassium hydroxide, avena sativa (oat) kernel extract, menthyl lactate, diazolidinyl urea, benzyl alcohol, methylparaben, BHT, propylparaben *Refers to the ingredient hydrocortisone †Contains 7 healing moisturizers and vitamins A, C & E CHATTEM® Distributed by CHATTEM, INC. P.O. Box 2219, Chattanooga, TN 37409-0219 USA ©2008 0040439-02 Cortizone-10 ® Ointment
Inactive Ingredients petrolatum *Refers to the ingredient hydrocortisone CHATTEM® Distributed by CHATTEM, INC. P.O. Box 2219, Chattanooga, TN 37409-0219 USA ©2008 www.chattem.com 0040437-02 Cortizone-10 ® Plus Cre me
Inactive Ingredients aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopheryl acetate, water, zea mays (corn) oil *Refers to the ingredient hydrocortisone CHATTEM® Distributed by CHATTEM, INC. P.O. Box 2219, Chattanooga,TN 37409-0219 USA ©2008 www.chattem.com 0040435-02
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor
Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor
Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor
Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor
Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch
Purpose Anti-itch
Purpose Anti-itch
Purpose Anti-itch
Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Cortizone 10 Cooling Relief Hydrocortisone HYDROCORTISONE HYDROCORTISONE ALOE VERA LEAF DIMETHICONE EDETATE DISODIUM GLYCERIN MALTODEXTRIN METHYLPARABEN POLYSORBATE 60 PROPYLPARABEN SODIUM CITRATE WATER CYCLOMETHICONE 5 ALCOHOL Cortizone 10 hydrocortisone HYDROCORTISONE HYDROCORTISONE ALOE VERA LEAF ALUMINUM SULFATE YELLOW WAX CALCIUM ACETATE CETOSTEARYL ALCOHOL GLYCERIN MALTODEXTRIN METHYLPARABEN MINERAL OIL PETROLATUM PROPYLPARABEN SODIUM CETOSTEARYL SULFATE SODIUM LAURYL SULFATE WATER Cortizone 10 Intensive Healing hydrocortisone HYDROCORTISONE HYDROCORTISONE WATER GLYCERIN DIMETHICONE PETROLATUM CETYL ALCOHOL ALOE VERA LEAF STEARYL ALCOHOL CETOSTEARYL ALCOHOL POLYSORBATE 60 VITAMIN A PALMITATE GLYCERYL MONOSTEARATE EDETIC ACID POTASSIUM HYDROXIDE DIAZOLIDINYL UREA BENZYL ALCOHOL METHYLPARABEN BUTYLATED HYDROXYTOLUENE PROPYLPARABEN ALPHA-TOCOPHEROL ACETATE Cortizone 10 Hydrocortisone HYDROCORTISONE HYDROCORTISONE PETROLATUM Cortizone 10 Plus Hydrocortisone HYDROCORTISONE HYDROCORTISONE ALOE VERA LEAF ALUMINUM SULFATE YELLOW WAX CALCIUM ACETATE CETOSTEARYL ALCOHOL CHOLECALCIFEROL GLYCERIN ISOPROPYL PALMITATE MALTODEXTRIN METHYLPARABEN MINERAL OIL PETROLATUM PROPYLENE GLYCOL PROPYLPARABEN VITAMIN A PALMITATE SODIUM CETOSTEARYL SULFATE SODIUM LAURYL SULFATE ALPHA-TOCOPHEROL ACETATE WATER CORN OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel Cooling gel formula itch relief Cools Itch Fast relief that lasts Sunburn Poison Ivy Insect Bites Inflammation and r edness Cools itch on Contact MAXIMUM STRENGTH Cortizone-10® C OOLING R ELIEF GEL Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch Gel Principal Display Panel Cooling gel formula itch relief Cools Itch Fast relief that lasts • Sunburn • Poison Ivy • Insect Bites Inflammation and redness Cools itch on Contact MAXIMUM STRENGTH Cortizone-10® COOLING RELIEF GEL Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch Gel
Principal Display Panel 10 Nourishing Ingredients Itch relief Fast Itch Lasts 10 Hours Eczema Sunburn Dry, Itchy Skin Inflammation & redness Hydrates irritated, itchy skin PLUS ULTRA MOISTURIZING MAXIMUM STRENGTH Cortizone-10 ® Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch CREME Principal Display Panel 10 Nourishing Ingredients Itch relief Fast Itch Lasts 10 Hours • Eczema • Sunburn • Dry, Itchy Skin Inflammation & redness Hydrates irritated, itchy skin PLUS ULTRA MOISTURIZING MAXIMUM STRENGTH Cortizone-10® Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch CREME
Principal Display Panel Fast Itch Relief Lasts 10 Hours 24 HOURS MOISTURIZING Itch Relief Eczema Psoriasis Itchy Skin Inflammation & redness Extra creamy formula, gentle on skin INTENSIVE HEALING FORMULA † MAXIMUM STRENGTH Cortizone-10 ® Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch Crème Principal Display Panel Fast Itch Relief Lasts 10 Hours 24 HOURS MOISTURIZING Itch Relief • Eczema • Psoriasis • Itchy Skin Inflammation & redness Extra creamy formula, gentle on skin INTENSIVE HEALING FORMULA† MAXIMUM STRENGTH Cortizone-10® Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch Crème
Principal Display Panel Fast Itch Relief Last 10 Hours Water Resistant Formula Itch Relief Psoriasis Poison Ivy Irritation & Rashes Inflammation & redness Locks in moisture Anti – Itch Ointment Helps Seal in Healing DOCTORS #1 ITCH MEDICINE* TM RECOMMEND THE ITCH MEDICINE DOCTORS RECOMMEND* MAXIMUM STRENGTH Cortizone-10 ® Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch OINTMENT Principal Display Panel Fast Itch Relief Last 10 Hours Water Resistant Formula Itch Relief • Psoriasis • Poison Ivy • Irritation & Rashes Inflammation & redness Locks in moisture Anti – Itch Ointment Helps Seal in Healing DOCTORS #1 ITCH MEDICINE*TM RECOMMEND THE ITCH MEDICINE DOCTORS RECOMMEND* MAXIMUM STRENGTH Cortizone-10® Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch OINTMENT
Principal Display Panel Fast Itch Relief Last 10 Hours Calming Aloe Vera Itch Relief Psoriasis Poison Ivy Insect Bites Inflammation & redness Soothes itch, irritation & rashes DOCTORS #1 ITCH MEDICINE* TM RECOMMEND MAXIMUM STRENGTH Cortizone-10 ® plus Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch CREME Principal Display Panel Fast Itch Relief Last 10 Hours Calming Aloe Vera Itch Relief • Psoriasis • Poison Ivy • Insect Bites Inflammation & redness Soothes itch, irritation & rashes DOCTORS #1 ITCH MEDICINE*TM RECOMMEND MAXIMUM STRENGTH Cortizone-10® plus Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch CREME
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Cortizone-10 ® Cooling Relief Gel
Other information contents filled by weight, not volume
Other information contents filled by weight, not volume
Other information contents filled by weight, not volume
Other information contents filled by weight, not volume
Other information contents filled by weight, not volume
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor.
Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor.
Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor.
Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor.
Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator
When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator
When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator
When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator
When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API