Label: THERACARE MAXIMUM STRENGTH 1% HYDROCORTISONE- hydrocortisone cream
- NDC Code(s): 71101-211-01
- Packager: Veridian Healthcare
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 4, 2021
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- Download DRUG LABEL INFO: PDF XML
- 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) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 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 not final part348 05/01/2021 Labeler - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Private Limited 916837425 manufacture(71101-211)
