DYNAREX ZINC OXIDE- zinc oxide ointment ointment

Dynarex Zinc Oxide by

Drug Labeling and Warnings

Dynarex Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 25%

Purpose

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

• condition worsens
• 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 excessive heat

Inactive Ingredients

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

Labeling

INGREDIENTS AND APPEARANCE

DYNAREX ZINC OXIDE 
zinc oxide ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250 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: 67777-119-00	28.4 g in 1 TUBE; Type 0: Not a Combination Product	03/27/2018
2	NDC: 67777-119-10	56.7 g in 1 TUBE; Type 0: Not a Combination Product	03/27/2018
3	NDC: 67777-119-20	425 g in 1 JAR; Type 0: Not a Combination Product	03/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/27/2018

Labeler - Dynarex Corporation (008124539)