HYDROCORTISONE ACETATE- hydrocortisone acetate cream 
Kinray Inc.

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

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

Warnings:

For external use only

Purpose

Hydrocortisone is 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 itching of;
genital
feminine and
anal itching

Indications and Usage

Stop use and ask a physician if:

Keep out of reach of children

Dosage and Administration

Adults and children over 2 years of age
Children under 2 years of age
Adults

Other information:

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Edetate sodium, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphate, White soft paraffin.

Principal Display Panel

KR-1139

Hydrocortisone.jpg

Hydrocortisone

HYDROCORTISONE ACETATE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-224
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
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-224-0128.4 g in 1 TUBE; Type 0: Not a Combination Product09/06/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/29/2011
Labeler - Kinray Inc. (012574513)
Registrant - Dynarerx Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Pvt. Ltd.864201135manufacture(63777-224)
Establishment
NameAddressID/FEIBusiness Operations
Blossom Pharmaceuticals677381470manufacture(63777-224)

Revised: 5/2016
Document Id: 1fa85348-d55e-4b27-8306-b78511ecb677
Set id: 94a776de-aa08-4274-ab07-48de6e934791
Version: 5
Effective Time: 20160506
 
Kinray Inc.