NIVAGEN ZINC OXIDE - zinc oxide ointment 
Nivagen Pharmaceuticals, 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 USP

ACTIVE INGREDIENT(S)

Zinc Oxide 20%

USE(S)

Skin Protectant

USES 

■    Helps treat and prevent diaper rash

■    Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac

WARNINGS

For External Use Only

When using this product ■ do not get into eyes

Stop use and ask a doctor if

■   conditionworsens

■   symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

■   For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

■   For poison ivy, oak, and sumac: Apply as needed.



OTHER INFORMATION

■   Store at room temperature

■   Avoid  excessiveheat

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

zincoxideoneoz

zincoxidetwooz

zincoxidefifteenoz
NIVAGEN ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75834-170
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
PETROLATUM (UNII: 4T6H12BN9U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75834-170-0128.4 g in 1 TUBE; Type 0: Not a Combination Product05/10/2018
2NDC:75834-170-0256.7 g in 1 TUBE; Type 0: Not a Combination Product05/10/2018
3NDC:75834-170-15425 g in 1 JAR; Type 0: Not a Combination Product05/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/10/2018
Labeler - Nivagen Pharmaceuticals, Inc. (052032418)

Revised: 2/2022
Document Id: c0fffe6a-f964-4a71-aac8-ca5d675e2168
Set id: 7b42655b-2163-4637-9f5d-1d2efa1bdf1d
Version: 5
Effective Time: 20220214
 
Nivagen Pharmaceuticals, Inc.