Label: THERACARE MAXIMUM STRENGTH 1% HYDROCORTISONE- hydrocortisone cream
- NDC Code(s): 71101-211-01
- Packager: Veridian Healthcare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose
-
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
- eczema
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
-
Warnings
For external use only
Do not use
- in the genital area if you have a vaginal discharge.
- for the treatment of diaper rash.
- with any other hydrocortisone product unless you have asked a doctor
When using this product
- use only as directed
- 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
-
Directions
- for itching of skin irritation, inflammation, and rashes:
- adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: consult a physician
-
for external anal and genital itching, adults and children 12 years of age and over:
- 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: consult a physician
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- Other information
- Inactive Ingredients
- TheraCare Maximum Strength 1% Hydrocortisone Cream
-
INGREDIENTS AND APPEARANCE
THERACARE MAXIMUM STRENGTH 1% HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) EDETATE SODIUM (UNII: MP1J8420LU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 60 (UNII: CAL22UVI4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71101-211-01 1 in 1 CARTON 05/01/2021 1 28.3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/01/2021 Labeler - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Private Limited 916837425 manufacture(71101-211)
