Your browser does not support JavaScript! ZINC OXIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]
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RxNorm Names

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


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredient:

Zinc Oxide (200 mg)

Purpose:

Skin protectant

Uses:

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

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

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

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

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 – LABEL

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 – CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC 0168-0062-16

Zinc Oxide
Ointment USP

NET WT 453.6 g (1 lb)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL
ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0168-0062
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
WHITE WAX 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0168-0062-311 in 1 CARTON
128.35 g in 1 TUBE
2NDC:0168-0062-021 in 1 CARTON
256.70 g in 1 TUBE
3NDC:0168-0062-16453.6 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/1968
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 9/2012
 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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