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| Product NDC Code | 41167-0028 | ||||
|---|---|---|---|---|---|
| Drug Name | Cortisone 10 sensitive skin creme |
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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 i ngredient
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 ■ 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: do not use, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.In active ingredients water, glycerin, dimethicone, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, dextrin, glyceryl stearate, isohexadecane, methyl gluceth-20, avena sativa (oat) kernel extract, tocopheryl acetate, magnesium ascorbyl phosphate, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, butyrospermum parkii (shea) butter extract, zingiber officinale (ginger) root extract, boswellia serrata gum, bisabolol, maltodextrin, ethylhexylglycerin, pentylene glycol, phenoxyethanol, disodium EDTA, dipropylene glycol, 4-t-butylcyclohexanol, benzoic acid, polysorbate 60, sodium citrate, citric acid
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.Use s ■ 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 ■ 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 Hydrocortisone 1%...........................................................................................................................................Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Cortisone 10 Sensitive Skin Creme Hydrocortisone HYDROCORTISONE HYDROCORTISONE WATER GLYCERIN DIMETHICONE PETROLATUM HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) CETYL ALCOHOL GLYCERYL MONOSTEARATE ISOHEXADECANE METHYL GLUCETH-20 OAT .ALPHA.-TOCOPHEROL ACETATE MAGNESIUM ASCORBYL PHOSPHATE ALOE VERA LEAF CHAMOMILE SHEA BUTTER GINGER INDIAN FRANKINCENSE LEVOMENOL MALTODEXTRIN ETHYLHEXYLGLYCERIN PENTYLENE GLYCOL PHENOXYETHANOL EDETATE DISODIUM ANHYDROUS DIPROPYLENE GLYCOL 4-TERT-BUTYLCYCLOHEXANOL BENZOIC ACID POLYSORBATE 60 SODIUM CITRATE CITRIC ACID MONOHYDRATE
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 Cortizone 10 Sensitive Skin Crème Net wt 2 oz (56 g) PRINCIPAL DISPLAY PANEL Cortizone 10 Sensitive Skin Crème Net wt 2 oz (56 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.Cortizone 10 Sensitive Skin Anti-itch Creme Drug Facts
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 ■ 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.
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 the 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 Do not use ■ for the treatment of diaper rash. Consult a doctor. When using this product ■ avoid contact with the 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