ZINC OXIDE- zinc oxide ointment 
Kinray Inc.

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

Helps treat and prevent diaper rash.
Dries the oozing and weeping of;
poison ivy
poison oak
poison sumac

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.

Inactive Ingredient 

Inactive ingredients: Light mineral oil, white petrolatum

Dosage and Administration

For diaper rash:

For poison ivy, poison oak, poison sumac:

Indications and Usage

Principal Display Panel

Zinc Oxide Ointment

zinc_oxide_ointment.jpg

zinc_oxide_ointment

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-222
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
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-222-0372 in 1 CASE
128.34 g in 1 TUBE
2NDC:63777-222-0172 in 1 CASE
256.68 g in 1 TUBE
3NDC:63777-222-0212 in 1 CASE
3425.1 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/19/2010
Labeler - Kinray Inc. (012574513)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma India Private Limited918531450manufacture(63777-222)
Establishment
NameAddressID/FEIBusiness Operations
Blossom Pharmaceuticals677381470manufacture(63777-222)

Revised: 4/2014
Document Id: 9d4c0af2-75b3-44a8-9f9d-da6758e04b0b
Set id: 215ce0cf-fd32-45ac-8320-a5c1ae61d8b8
Version: 4
Effective Time: 20140425
 
Kinray Inc.