Zinc Oxide by Topco Associates LLC ZINC OXIDE ointment

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash
• helps seal out wetness

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 within a few days.

Keep out of reach of children.

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

Directions

• change wet or soiled diapers promptly
• clean the diaper area
• allow to dry
• apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.

Other Information

• store at 20-25°C (68-77°F)

Inactive Ingredients

bees wax, BHT, cod liver oil, fragrance, lanolin, methylparaben, petrolatum, purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-100-02	1 in 1 BOX
1		56.7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2013

Labeler - Topco Associates LLC (006935977)