Label: ZINC OXIDE ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 26, 2013

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  • ACTIVE INGREDIENT

    Section Text

    Active Ingredient                            Purpose

    Zinc Oxide (200mg in each gram)   Skin Protectant

  • Uses:

    • Helps treat and prevent diaper rash.
    • Dries the oozing and weeping of;
    • poison ivy
    • poison oak
    • poison sumac
  • Warnings:

    For External Use Only

  • When using this product:

    • Do not get in eyes.
  • Stop use and ask a doctor if:

    • conditions worsens
    • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician.
    • over large areas of the body
    • if you are allergic to any of these ingredients
  • Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

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

  • Directions:

    For diaper rash:

    • change wet and soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

    For poison ivy, poison oak, poison sumac:

    • apply liberally as often as needed
  • Inactive Ingredients

    Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

  • Principal Display

    Galzinc.jpg

    Galentic zinc oxide

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-051
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-051-0372 in 1 CASE
    128.34 g in 1 TUBE
    2NDC:50382-051-0172 in 1 CASE
    256.68 g in 1 TUBE
    3NDC:50382-051-0212 in 1 CASE
    3425.1 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/19/2013
    Labeler - Galentic Pharma (India) Priva Te Limited (918531450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-051)
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