Label: THERACARE HYDROCORTISONE CREAM- hydrocortisone cream
- NDC Code(s): 71101-220-01
- Packager: Veridian Healthcare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 21, 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
- 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
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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
- Other information
- Inactive Ingredients
- TheraCare Hydrocortisone Cream
-
INGREDIENTS AND APPEARANCE
THERACARE HYDROCORTISONE CREAM
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-220 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) MINERAL OIL (UNII: T5L8T28FGP) WHITE PETROLATUM (UNII: B6E5W8RQJ4) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71101-220-01 1 in 1 CARTON 07/01/2023 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 07/01/2023 Labeler - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations Nantong Health & Beyond Hygienic Products Inc. 421280161 manufacture(71101-220)