NIVAGEN ZINC OXIDE- zinc oxide ointment

NIVAGEN ZINC OXIDE by

Drug Labeling and Warnings

NIVAGEN ZINC OXIDE by is a Otc medication manufactured, distributed, or labeled by Nivagen Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Zinc Oxide 20%

USE(S)

Skin Protectant

INDICATIONS & USAGE

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

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

INGREDIENTS AND APPEARANCE

NIVAGEN ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75834-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75834-170-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	05/10/2018
2	NDC: 75834-170-02	56.7 g in 1 TUBE; Type 0: Not a Combination Product	05/10/2018
3	NDC: 75834-170-15	425 g in 1 JAR; Type 0: Not a Combination Product	05/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	05/10/2018

Labeler - Nivagen Pharmaceuticals, Inc. (052032418)