Label: PIPETTE DIAPER RASH- zinc oxide cream

  • NDC Code(s): 73517-427-01, 73517-427-02, 73517-427-03
  • Packager: Amyris, Inc
  • 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 November 3, 2022

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  • Active Ingredients

      Zinc Oxide 14%

    Purpose

    Ski Protectant

  • Uses

    • helps treat and prvent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    • For external use only

    When using this product

    • do not get into eyes

    Stop use and aks a doctor if

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

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •   Change wet and soiled diapers promptly
    • cleanse the diaper area
    • allow to dry
    • apply cream liberally as often as necessary, with each diaper change, and especially at betime or any time when exposure to wet diapers may be prolonged.
  • Other information

    Protect this product from excessive heat and direct sunlight

  • Inactive Ingredients

    Glycerin, Squalane, Butyrospermum Parkii (Shea ) Butter, Jojoba Esters, Euterpe Oleracea Sterols,
    Polyglyceryl-2 Dipolyhydroxystearate, Sorbitan Olivate, 1,2-Hexandiol, Caprylyl Glycol, Bisabolol, Linoleic Acid, Oleic
    Acid, Linolenic Acid, Tocopherol.

  • PRINCIPAL DISPLAY PANEL

    DiaperCrmUC

  • INGREDIENTS AND APPEARANCE
    PIPETTE DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-427
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION14 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALANE (UNII: GW89575KF9)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) (UNII: AS2SZ9757N)  
    EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73517-427-021 in 1 CARTON02/01/2021
    1NDC:73517-427-0188.7 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:73517-427-0330 mL in 1 TUBE; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01602/01/2021
    Labeler - Amyris, Inc (185930182)
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