Label: NIVAGEN ZINC OXIDE- zinc oxide ointment

  • NDC Code(s): 75834-170-01, 75834-170-02, 75834-170-15
  • Packager: Nivagen Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 14, 2022

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  • ACTIVE INGREDIENT(S)

    Zinc Oxide 20%

  • USE(S)

    Skin Protectant

  • INDICATIONS & USAGE

    USES 

    ■    Helps treat and prevent diaper rash

    ■    Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac

  • WARNINGS

    For External Use Only

    When using this product ■ do not get into eyes

    Stop use and ask a doctor if

    ■   conditionworsens

    ■   symptoms last more than 7 days or clear up and occur again within a few days

  • 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 as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

    ■   For poison ivy, oak, and sumac: Apply as needed.



  • OTHER INFORMATION

    ■   Store at room temperature

    ■   Avoid  excessiveheat

  • INACTIVE INGREDIENTS

    Cetomacrogol 1000, Cetostearyl Alcohol, Light Liquid Paraffin, White Soft Paraffin

  • PRINCIPAL DISPLAY PANEL

    zincoxideoneoz

    zincoxidetwooz

    zincoxidefifteenoz
  • INGREDIENTS AND APPEARANCE
    NIVAGEN ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75834-170
    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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75834-170-0128.4 g in 1 TUBE; Type 0: Not a Combination Product05/10/2018
    2NDC:75834-170-0256.7 g in 1 TUBE; Type 0: Not a Combination Product05/10/2018
    3NDC:75834-170-15425 g in 1 JAR; Type 0: Not a Combination Product05/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/10/2018
    Labeler - Nivagen Pharmaceuticals, Inc. (052032418)
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