Label: ASTONEA- hydrocortisone cream
- NDC Code(s): 77338-305-02, 77338-305-03, 77338-305-06
- Packager: ASTONEA LABS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 25, 2024
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- Download DRUG LABEL INFO: PDF XML
- 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
ASTONEA
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-305 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:77338-305-02 0.9 g in 1 PACKET; Type 0: Not a Combination Product 05/02/2022 2 NDC:77338-305-03 28.3 g in 1 TUBE; Type 0: Not a Combination Product 05/02/2022 3 NDC:77338-305-06 454 g in 1 JAR; Type 0: Not a Combination Product 05/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/02/2022 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295) Establishment Name Address ID/FEI Business Operations ASTONEA LABS PRIVATE LIMITED 878533295 manufacture(77338-305)