Label: HYDROCORTISONE cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 0924-1132-01, 0924-1132-02, 0924-1132-03, 0924-1132-04 - Packager: Acme United Corp
- Category: HUMAN OTC DRUG LABEL
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 March 9, 2016
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- Principal Display Panel - 0.9g Carton Label
- Principal Display Panel - 0.9g Packet Label
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-1132 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 10 mg in 1 g Inactive Ingredients Ingredient Name Strength alcohol (UNII: 3K9958V90M) methylparaben (UNII: A2I8C7HI9T) mineral oil (UNII: T5L8T28FGP) paraffin (UNII: I9O0E3H2ZE) petrolatum (UNII: 4T6H12BN9U) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) white wax (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-1132-02 12 in 1 CARTON 1 NDC:0924-1132-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-1132-03 144 in 1 CARTON 2 NDC:0924-1132-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0924-1132-04 25 in 1 CARTON 3 NDC:0924-1132-01 0.9 g in 1 PACKET; 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 11/06/2015 Labeler - Acme United Corp (001180207) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(0924-1132)