Label: MAXIMUM STRENGTH DIAPER RASH- zinc oxide ointment 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 January 29, 2021

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  • Active ingredient

    Zinc Oxide, 40%

  • Purpose

    Skin protectant

  • Uses

    helps treat and prevent diaper rash, Protects chafed skin due to diaper rash and helps seal out wetness

  • 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 7 days

  • Keep out of reach of children

    to prevent accidential ingestion.  If swallowed, seek medical help or call Poison Control Center immediately.

  • Directions for Use

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

  • Other information

    Storage temperature: not to exceed 30oC (86oF),

    Remove foil seal from the tube's tip,

    Use with infants, children, and adults,

    Will stain clothing and fabric

  • Inactive ingredients

    Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, White Petrolatum

  • Package label

    Package label

  • Tube label

    Tube label

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH DIAPER RASH 
    zinc oxide ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-849
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U) 31 g  in 100 g
    MINERAL OIL (UNII: T5L8T28FGP) 20 g  in 100 g
    PARAFFIN (UNII: I9O0E3H2ZE) 1 g  in 100 g
    CASTOR OIL (UNII: D5340Y2I9G) 3.5 g  in 100 g
    BALSAM PERU (UNII: 8P5F881OCY) 4.5 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-849-04113 g in 1 TUBE; Type 0: Not a Combination Product07/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/22/2016
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(59779-849)
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