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| Product NDC Code | 41167-0335 | ||||
|---|---|---|---|---|---|
| Drug Name | Cortizone 10 intensive healing feminine itch relief |
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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, 206352 |
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| Application Number | M017 | ||||
| Labeler Name | Chattem, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.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 when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly then gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product adults and children 12 years of age and older: apply a fingertip amount (approximately 1-inch strip) 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 ingredients water, glycerin, dimethicone, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-21, steareth-2, chomomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, retinyl palmitate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, beta-glucan, glyceryl stearate, menthyl lactate, polysorbate 60, methyl gluceth-20, stearamidopropyl PG-dimonium chloride phosphate, PPG-12/SMDI copolymer, potassium hydroxide, diazolidinyl urea, propylene glycol, benzyl alcohol, methylparaben, BHT, propylparaben, EDTA (309-011)
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 external feminine 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
Spl product data elements
Usually a list of ingredients in a drug product.Cortizone 10 Intensive Healing Feminine Itch Relief Hydrocortisone HYDROCORTISONE HYDROCORTISONE WATER GLYCERIN DIMETHICONE PETROLATUM JOJOBA OIL, RANDOMIZED CETYL ALCOHOL ALOE VERA LEAF STEARYL ALCOHOL DISTEARYLDIMONIUM CHLORIDE CETOSTEARYL ALCOHOL STEARETH-21 STEARETH-2 CHAMOMILE ALPHA-TOCOPHEROL ACETATE MAGNESIUM ASCORBYL PHOSPHATE VITAMIN A PALMITATE HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) HYDROLYZED JOJOBA ESTERS (ACID FORM) GLYCERYL MONOSTEARATE MENTHYL LACTATE, (-)- POLYSORBATE 60 METHYL GLUCETH-20 STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE PPG-12/SMDI COPOLYMER POTASSIUM HYDROXIDE DIAZOLIDINYL UREA PROPYLENE GLYCOL BENZYL ALCOHOL METHYLPARABEN BUTYLATED HYDROXYTOLUENE PROPYLPARABEN EDETIC ACID
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 Maximum Strength Cotizone 10 ® FEMININE ITCH RELIEF Anti-Itch Crème For Feminine Itch 1% Hydrocortisone Anti-Itch Creme Net wt 1 oz (28 g) Maximum Strength Cotizone 10® FEMININE ITCH RELIEF Anti-Itch Crème For Feminine Itch 1% Hydrocortisone Anti-Itch Creme Net wt 1 oz (28 g)
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.Maximum Strength Cotizone 10 ® Feminine Relief Anti-Itch Creme Drug Facts
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.
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
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
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 When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor 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 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