AFTATE HYDROCORTISONE CREAM- hydrocortisone cream cream 
Sabel Med LLC

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.

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Hydrocortisone Cream USP 1% 1 oz

dosage and administration

inactives

active

keep out of reach

purpose

warnings

uses

principle display

AFTATE HYDROCORTISONE CREAM 
hydrocortisone cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70356-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETETH-20 (UNII: I835H2IHHX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CHLOROCRESOL (UNII: 36W53O7109)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70356-201-0128 g in 1 TUBE; Type 0: Not a Combination Product05/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2016
Labeler - Sabel Med LLC (091476000)

Revised: 3/2016
Document Id: 2b390b06-cac6-4daa-e054-00144ff8d46c
Set id: 2b390b06-cac5-4daa-e054-00144ff8d46c
Version: 1
Effective Time: 20160331
 
Sabel Med LLC