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 February 16, 2011

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  • ACTIVE INGREDIENT


    Active ingredient                      Purpose

    Zinc Oxide........................................Skin protectant
  • PURPOSE


    Active ingredient                 Purpose

    Zinc Oxide.................................Skin protectant

    Uses

    - dries the oozing and weeping od poison - ivy - oak - sumac
    - helps treat and prevent diaper rash
    - protects chafed skin associated with diaper rash and helps protect from wetness

  • KEEP OUT OF REACH OF CHILDREN


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


    Uses

    - dries the oozing and weeping od poison - ivy - oak - sumac
    - helps treat and prevent diaper rash
    - protects chafed skin associated with diaper rash and helps protect from wetness
  • WARNINGS

    Warnings

    For external use only.

    When using this product do not get into eyes


    Stop use and ask a doctor if:

    - condition worsens  - symptoms last more than 7 days or clear
    up and occur again within a few days.

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION


    Directions

    - apply as needed

    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

    - children under 12 years

    ask a doctor

    Other information

    Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

  • INACTIVE INGREDIENT


    Inactive Ingredients

    beeswax, mineral oil, petrolatum

  • PRINCIPAL DISPLAY PANEL

    c
  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0081
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0081-357 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/19/2009
    Labeler - RiteAid (014578892)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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