LINCOLN- hydrocortisone acetate cream 
Lincoln Pharmaceuticals Ltd.

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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Drug Facts

Hydrocortisone Acetate USP (1 % W/W)

Drug Facts

Anti-Itch

Drug Facts

for external use only

USES

Drug Facts

Drug Facts

If you are pregnant or breast- feeding

Drug Facts

Drug Facts

Drug facts

For Itching of skin irritation, inflammation and rashes:

Children under 2 years of age

For External anal and genital itching, adults:

Drug Facts

Cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

Drug Facts:

Package Label

principal display panel

LINCOLN 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-3050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69636-3050-20.9 g in 1 PACKET; Type 0: Not a Combination Product05/23/2013
2NDC:69636-3050-328.3 g in 1 TUBE; Type 0: Not a Combination Product05/23/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/23/2013
Labeler - Lincoln Pharmaceuticals Ltd. (915839373)
Establishment
NameAddressID/FEIBusiness Operations
Lincoln Pharmaceuticals Ltd.915839373manufacture(69636-3050)

Revised: 4/2016
Document Id: 2fbe9ae0-52d8-298a-e054-00144ff8d46c
Set id: 2fbe9ae0-52d7-298a-e054-00144ff8d46c
Version: 1
Effective Time: 20160405
 
Lincoln Pharmaceuticals Ltd.