Zinc Oxide by Ultra Seal Corporation ZINC OXIDE ointment

Zinc Oxide by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Zinc oxide 20%

PURPOSE

Purpose: Skin Protectant

INDICATIONS & USAGE

Dries the oozing and weeping of poison ivy, poison oak, and sumac.  Helps treat/prevent diaper rash. Protects chafed skin associated with diaper rash and helps protect from wetness.

WARNINGS

For external use only. When using this product, avoid contact with eyes.

Stop use and ask a doctor if condition worsens or does not improve in 7 days

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Inactive Ingredient:  White Petrolatum

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42213-365
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
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42213-365-48	1 in 1 CARTON	05/03/2012
1	NDC: 42213-365-56	56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/03/2012

Labeler - Ultra Seal Corporation (085752004)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	manufacture(42213-365)