Label: LINCOLN- hydrocortisone acetate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69636-3050-2, 69636-3050-3 - Packager: Lincoln Pharmaceuticals Ltd.
- 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 April 5, 2016
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INDICATIONS & USAGE
USES
- For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy position sumac, poison oak, 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
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Drug facts
For Itching of skin irritation, inflammation and rashes:
- 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
For External anal and genital itching, 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 upto 6 times daily or after each bowel movement
- after application, discard pad
- do not flush in toilet
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INGREDIENTS AND APPEARANCE
LINCOLN
hydrocortisone acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69636-3050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength CHLOROCRESOL (UNII: 36W53O7109) CETETH-20 (UNII: I835H2IHHX) EDETATE DISODIUM (UNII: 7FLD91C86K) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H) WATER (UNII: 059QF0KO0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PETROLATUM (UNII: 4T6H12BN9U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69636-3050-2 0.9 g in 1 PACKET; Type 0: Not a Combination Product 05/23/2013 2 NDC:69636-3050-3 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 - Lincoln Pharmaceuticals Ltd. (915839373) Establishment Name Address ID/FEI Business Operations Lincoln Pharmaceuticals Ltd. 915839373 manufacture(69636-3050)