ZINC OXIDE- zinc oxide ointment
Ultra Seal Corporation

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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Drug Facts

Active Ingredients Zinc oxide 20%

Purpose: Skin Protectant

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.

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

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: White Petrolatum

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

Zn o 2 oz tube

ZINC OXIDE
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42213-365
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42213-365-48	1 in 1 CARTON	05/03/2012	01/01/2022
1	NDC:42213-365-56	56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/03/2012	01/01/2022

Labeler - Ultra Seal Corporation (085752004)

Registrant - Ultra Seal Corporation (085752004)

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

Revised: 1/2023

Document Id: f19fdee8-82b5-47c8-e053-2a95a90a2f4e

Set id: e45ac82c-508c-4c41-ba2c-f48d36bc63fe

Version: 4

Effective Time: 20230106

Ultra Seal Corporation