Zinc Oxide by Gandhar Oil Refinery India Ltd Zinx Oxide 20%

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Gandhar Oil Refinery India Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZINC OXIDE- zinc oxide ointment 
Gandhar Oil Refinery India Ltd

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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Zinx Oxide 20%

For external use only.

When using this product do not get in eyes.

Stop use and ask doctor if

Condition worsens.

Symptoms last more than 7 days or clear up and occur again within a few days.

Purpose:

Skin Protectant

Uses:

Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urine. Protects chafed skin due to diaper rash and helps seal out wetness.

Directions:

Change wet and soiled diapers promptly.
Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry.
Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled dapers (feces, and/or urine) may be prolonged.

Mineral Oil and petrolatum

Apply Liberally as often as necessary

Keep out of reach of childern- if swalloed , get medical help or conact a posion control center right away

Skin Proctetant

Zinc Oxide 20%

Label

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79042-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79042-003-01170 kg in 1 DRUM; Type 0: Not a Combination Product03/17/202104/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/17/202104/18/2022
Labeler - Gandhar Oil Refinery India Ltd (725188184)
Establishment
NameAddressID/FEIBusiness Operations
Gandhar Oil Refinery India Ltd725188184manufacture(79042-003)

Revised: 5/2022
Document Id: df581b4b-a815-53ee-e053-2a95a90ab629
Set id: bdbac073-3a78-3e48-e053-2a95a90a0b4b
Version: 2
Effective Time: 20220519