Label: GLINT- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71486-3050-2, 71486-3050-3 - Packager: GLINT COSMETICS PRIVATE LIMITED
- 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, 2018
If you are a consumer or patient please visit this version.
- 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 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GLINT
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71486-3050 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:71486-3050-2 0.9 g in 1 PACKET; Type 0: Not a Combination Product 05/23/2013 2 NDC:71486-3050-3 28.3 g in 1 TUBE; Type 0: Not a Combination Product 05/23/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/23/2013 Labeler - GLINT COSMETICS PRIVATE LIMITED (675910492) Establishment Name Address ID/FEI Business Operations GLINT COSMETICS PRIVATE LIMITED 675910492 manufacture(71486-3050)