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

Drug Label Information

Updated December 4, 2024

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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)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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)  
    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 DrugM02002/01/2021
    Labeler - Amyris, Inc (185930182)
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