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

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient                      Purpose
    Zinc oxide 18%.........................Skin protectant
  • PURPOSE

    Uses
    - helps treat and prevent diaper rash
    - protects chafed skin due to diaper rash and
    helps seal out wetness
  • 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.
  • INDICATIONS & USAGE

    Uses
    - helps prevent and treat diaper rash
    - protects chafed skin due to diaper rash and
    helps seal out wetness


  • WARNINGS

    Warnings
    For external use only.
    _______________________________

    When using this product avoid contact with the eyes
    _______________________________

    Stop use and ask a doctor if condition worsens
    or does not improve after seven days

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


    Directions
    - change wet and soiled diapers immediately
    - cleanse the diaper area and allow to dry
    - apply ointment liberally and as often as necessary
    with each diaper change and especially when
    exposed to wet diapers for a prolonged period of
    time such as bedtime.
    _______________________________

    Other information

    - Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
    - use with infants children and adults
    - will stain clothing and fabric
  • INACTIVE INGREDIENT

    Inactive Ingredients castor oil, citric acid,
    mineral oil, paraffin, Peruvian balsam, petrolatum

  • PRINCIPAL DISPLAY PANEL

    label


  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE160 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-083-02113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/19/2009
    Labeler - CVS (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!