Label: CMC ZINC OXIDE- 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 September 11, 2017

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  • Active ingredient

    Zinc Oxide (20% w/w)

  • Purpose

    Skin Protectant

  • Purpose

    • 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 into eyes
    • do not use over large areas of the body
  • Stop use and ask a doctor if

    • if condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • if you are allergic to any of these ingredients
  • 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 any time when exposure to wet diapers may be prolonged
    • for poison ivy, oak, sumac
    • apply ointment liberally as often as needed
  • Other information

    • store at 56°-86° F (15-30°C)
    • avoid excessive heat
  • Inactive ingredients

    cetostearyl alcohol, cetomacrogol 1000, light liquid paraffin, white soft paraffin

  • PACKAGE LABEL

    Drug factFront display

  • INGREDIENTS AND APPEARANCE
    CMC ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71168-3040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71168-3040-328 g in 1 TUBE; Type 0: Not a Combination Product09/01/2017
    2NDC:71168-3040-456 g in 1 TUBE; Type 0: Not a Combination Product09/01/2017
    3NDC:71168-3040-5425 g in 1 JAR; Type 0: Not a Combination Product09/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2017
    Labeler - SKYLARK CMC PRIVATE LIMITED (650174824)
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