Label: GERIGENTLE- hydrocortisone cream
- NDC Code(s): 69771-192-13
- Packager: GERI-GENTLE CORPORATION
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 23, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Uses
■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor
- Warnings
- Do not use
- Ask a doctor before use
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
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Directions
■ adults and children over 2 years of age
■ apply evenly to affected area no more than 3 to 4 times daily
■ children under 2 years of age■ do not use, consult a doctor
■ Adults
■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying
■ apply externally to the area up to 6 times a daily or after a bowel movement
■ after application discard pad
■ do not flush in toilet
- Other information
- Inactive Ingredients
- Package Label
-
INGREDIENTS AND APPEARANCE
GERIGENTLE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69771-192 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) CETETH-20 (UNII: I835H2IHHX) EDETATE DISODIUM (UNII: 7FLD91C86K) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69771-192-13 28.3 g in 1 TUBE; Type 0: Not a Combination Product 11/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 11/23/2023 Labeler - GERI-GENTLE CORPORATION (080367686)