HYDROCORTISONE- hydrocortisone cream 
Galentic Pharma (India) Priva Te Limited

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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Galentic Hydrocortisone Cream 1%

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

Purpose:

For temporary relief of;

Itching and rashes due to;


and for external itching of;

Warnings:

For external use only

Do not use:

Stop use and ask a physician if:

Keep out of reach of children

Directions:

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

Other information:

Inactive ingredients:

Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Sodium Betabisulphite, White Soft Paraffin, Water (purified)

For temporary relief of minor skin irritations and external itching.

Principal Display Panel

Hydrocortisone 1%

Hydrocortisone Cream.jpg

Hydrocortisone

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-010
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-010-0128.3 g in 1 TUBE
2NDC:50382-010-02425 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/07/2013
Labeler - Galentic Pharma (India) Priva Te Limited (918531450)

Revised: 8/2013
Document Id: a66e7c0f-e3f8-4b5d-8e07-4522c86b6c38
Set id: eb49a81d-35d8-415c-a6a4-111eeb7125fc
Version: 1
Effective Time: 20130807
 
Galentic Pharma (India) Priva Te Limited