ZINC OXIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]

ZINC OXIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]
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NDC 0168-0062-02, 0168-0062-16, 0168-0062-31
Set ID ee65a059-7df4-4d5e-a70e-14861764597e
Category HUMAN OTC DRUG LABEL
Packager E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number PART347
  • 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 – 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
  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    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)