HYDROCORTISONE ACETATE- hydrocortisone acetate ointment 
Galentic Pharma (India) Private 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 Ointment 1%

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

Purpose

Hydrocortisone is for temporary relief of;

Itching and rashes due to;


and for external itching of;

Warnings:

For external use only

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:

Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Hydrocortisone

Gal Hydro Ointment.jpg

Hydrocortisone

HYDROCORTISONE ACETATE 
hydrocortisone acetate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-007
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
PARAFFIN (UNII: I9O0E3H2ZE)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-007-0128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/06/2011
Labeler - Galentic Pharma (India) Private Limited (918531450)

Revised: 8/2013
Document Id: c9bb6350-4876-4aa2-8986-51dc17925315
Set id: 3c63f324-d9ad-4e41-8e54-fa7487da619e
Version: 1
Effective Time: 20130807
 
Galentic Pharma (India) Private Limited