ZINC OXIDE- zinc oxide ointment 
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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Zinc Oxide Ointment

Section Text

Active Ingredient                            Purpose

Zinc Oxide (200mg in each gram)   Skin Protectant

Uses:

Warnings:

For External Use Only

When using this product:

Stop use and ask a doctor if:

Do not use on:

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For diaper rash:

For poison ivy, poison oak, poison sumac:

Inactive Ingredients

Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

Principal Display

Galzinc.jpg

Galentic zinc oxide

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-051-0372 in 1 CASE
128.34 g in 1 TUBE
2NDC:50382-051-0172 in 1 CASE
256.68 g in 1 TUBE
3NDC:50382-051-0212 in 1 CASE
3425.1 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/19/2013
Labeler - Galentic Pharma (India) Priva Te Limited (918531450)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-051)

Revised: 7/2013
Document Id: e1464e9e-9350-4572-ba59-c4c26535fec3
Set id: 1deec882-5c29-44f8-8a74-4ec5bed2eadc
Version: 4
Effective Time: 20130726
 
Galentic Pharma (India) Priva Te Limited