ZINC OXIDE- zinc oxide ointment 
Geri-Gentle 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

Drug Facts

Active ingredient

Zinc Oxide (20%w/w)

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product

  • do not get into eyes
  • do not use over large area of the body

Stop Use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days
  • if you are allergic to any of these ingredients

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions for Diaper Rash

Other information

Inactive Ingredients

Cetostearyl Alcohol, Cetomacrogol 1000, Lanolin, Light Liquid Paraffin, White Soft Paraffin

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Box

Principal Display and Drug Fact Panel

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69771-109-381 in 1 BOX01/15/2017
128.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69771-109-391 in 1 BOX01/15/2017
256.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/15/2017
Labeler - Geri-Gentle Corporation (080367686)

Revised: 8/2021
Document Id: cadd9fe3-fd6e-fc4b-e053-2a95a90ad512
Set id: f5cfab62-8aab-4109-b15b-4fe380f7cb9e
Version: 3
Effective Time: 20210831
 
Geri-Gentle Corporation