ZINC OXIDE 20%- zinc oxide ointment 
GERITREX LLC

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 20% Ointment

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions

apply liberally as often as necessary

For diaper rash:

  • change wet or soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

Store at controlled room temperature 20°-25°C (68°-77°F).

Inactive ingredients

mineral oil, petrolatum

28g Label

56g Label

454g Label

ZINC OXIDE 20% 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-040-2828 g in 1 TUBE; Type 0: Not a Combination Product09/17/2018
2NDC:54162-040-5656 g in 1 TUBE; Type 0: Not a Combination Product09/17/2018
3NDC:54162-040-16454 g in 1 JAR; Type 0: Not a Combination Product09/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/17/2018
Labeler - GERITREX LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
GERITREX LLC112796248manufacture(54162-040)

Revised: 9/2018
Document Id: b37f58ee-a452-49db-940b-64a709638c6b
Set id: c3e0af81-b21a-4c09-8ec4-64d1b658b870
Version: 1
Effective Time: 20180905
 
GERITREX LLC