Label: CARE ONE HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream
- NDC Code(s): 41520-319-64
- Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 February 10, 2020
If you are a consumer or patient please visit this version.
- 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
-
Warnings
For external use only
Do not use
- •
- in the genital area if you have a vaginal discharge. Consult a doctor.
- •
- 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
- •
- 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 older: apply to affected area not more than 3 to 4 times daily
- •
- children under 2 years of age: do not use, consult a doctor
- •
- for external anal and genital itching, adults:
- •
- 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 doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
CARE ONE HYDROCORTISONE MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-319 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL PALMITATE (UNII: 5ZA2S6B08X) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-319-64 1 in 1 CARTON 05/12/2017 1 28 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 05/28/2010 Labeler - American Sales Company (809183973)
