ZINC OXIDE by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ZINC OXIDE ointment

ZINC OXIDE by

Drug Labeling and Warnings

ZINC OXIDE by is a Otc medication manufactured, distributed, or labeled by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Zinc Oxide (200 mg)

Purpose:

Skin protectant

INDICATIONS & USAGE

Uses:

• helps treat and prevent diaper rash
• dries the oozing and weeping of:
• poison ivy
• poison oak
• poison sumac

WARNINGS

Warnings:

If condition worsens or dose not improve within seven days, consult physician.

Keep out of reach of children.

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

FOR EXTERNAL USE ONLY

AVOID CONTACT WITH EYES

DOSAGE & ADMINISTRATION

Directions:

• For diaper rash:
• change wet and soiled diapers promptly, allow to dry
• apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. To dry the oozing and weeping of poison ivy, poison oak or poison sumac:
• apply ointment liberally as often as needed

SPL UNCLASSIFIED SECTION

Other information:

• do not use if seal is punctured or is not visible
• use cap to puncture seal
• store at temperature
• do not exceed 30° C (86° F)

Inactive Ingredients

mineral oil, white petrolatum, white wax

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

NDC: 0168-0062-31

Fougera®

Zinc Oxide Ointment USP

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

NDC: 0168-0062-31

Fougera®

Zinc Oxide Ointment USP

Skin Protectant

To reliably help soothe and protect chafed skin.

INDICATION: Helps and prevent diaper rash. Protects chafed skin due to diaper rash and helps protect from wetness. Dries the oozing and weeping of poison ivy, poison oak and poison sumac.

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC: 0168-0062-16

Zinc Oxide
Ointment USP

NET WT 453.6 g (1 lb)

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0062
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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0062-31	1 in 1 CARTON
1		28.35 g in 1 TUBE
2	NDC: 0168-0062-02	1 in 1 CARTON
2		56.70 g in 1 TUBE
3	NDC: 0168-0062-16	453.6 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/1968

Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)