ZINC OXIDE- zinc oxide 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.

----------

Galentic GalShield Ointment

Active Ingredient               Purpose

Zinc Oxide (1.8% w/w)      Skin Protectant

Uses:

Warnings:

For External Use Only.

When using this product:

Do not get in eyes.

Stop use and ask a doctor if:

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage and Administration:

For skin protectant:

For diaper Rash:

Other information:

Indications and Usage: For use as a general skin protectant and diaper rash.

Inactive Ingredients

Inactive ingredients:

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water


Principal Display Panel

Galentic GalShield

GalShield.jpg

Galentic GalShield

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
CETETH-10 (UNII: LF9X1PN3XJ)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARETH-20 (UNII: L0Q8IK9E08)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
VITAMIN A (UNII: 81G40H8B0T)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PETROLATUM (UNII: 4T6H12BN9U)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-011-01114 g in 1 TUBE
2NDC:50382-011-02427.5 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/08/2013
Labeler - Galentic Pharma (India) Private Limited (918531450)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited918531450manufacture(50382-011)

Revised: 8/2013
Document Id: 646352db-de91-4a3f-9681-ec47226fa11a
Set id: e24b5acd-6094-4d4d-a027-81359133e7a8
Version: 1
Effective Time: 20130809
 
Galentic Pharma (India) Private Limited