ZINC OXIDE- zinc oxide ointment 
Dynarex Corporation

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

image description Dynarex zinc oxide

zinc.jpg

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-222
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
CETETH-20 
LIGHT MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-222-0372 in 1 CASE
128.34 g in 1 TUBE
2NDC:67777-222-0172 in 1 CASE
256.68 g in 1 TUBE
3NDC:67777-222-0212 in 1 CASE
3425.1 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/16/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma India Private Limited918531450manufacture(67777-222)

Revised: 12/2012
Document Id: 4169c44c-0e72-481c-a696-acbcd8391dfe
Set id: 9b4e0661-5d0a-4002-bc66-b1246ec6b858
Version: 3
Effective Time: 20121203
 
Dynarex Corporation