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

Purpose:

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

zinc oxide

zinc.jpg

ZINC OXIDE 
zinc oxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-222
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67777-222-03 72 in 1 CASE
1 28.34 g in 1 TUBE
2 NDC:67777-222-01 72 in 1 CASE
2 56.68 g in 1 TUBE
3 NDC:67777-222-02 12 in 1 CASE
3 425.1 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 03/16/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
Name Address ID/FEI Business Operations
Galentic Pharma (India) Pvt. Ltd. 864201135 manufacture(67777-222)
Establishment
Name Address ID/FEI Business Operations
Blossom Pharmaceuticals 677381470 manufacture(67777-222)

Revised: 9/2014
Document Id: 7051fce6-dc97-4d02-85a7-0f26c545a1ed
Set id: 9b4e0661-5d0a-4002-bc66-b1246ec6b858
Version: 5
Effective Time: 20140904
 
Dynarex Corporation