Label: CALMING DIAPER RASH- zinc oxide cream

  • 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 2, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 12%

  • Purpose

    Skin Protectant

  • Uses

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

    For external use only

    When using this product keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if condition worsens. If 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

    • apply an even layer for everyday protection and when a rash is present
  • Other information

    • protect the product in this container from excessive heat and direct sunlight
    • report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016
  • Inactive ingredients

    Water, glyceryl stearate, cetearyl alcohol, glyceryl caprylate, lanolin, calendula officinalis flower extract, viola tricolor extract, cocos nucifera (coconut) oil, caprylic/capric triglyceride, glycerin, cetyl alcohol, levulinic acid, squalane, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, melaleuca alternifolia (tea tree) leaf oil, carthamus tinctorius (safflower) oleosomes, p-anisic acid, allantoin, xanthan gum, oenothera biennis (evening primrose) oil, phytic acid, yucca schidigera root extract, aloe barbadensis leaf juice, stearyl glycyrrhetinate.

  • PRINCIPAL DISPLAY PANEL - 82 g Tube Label

    CALIF♥RNIA BABY®
    trusted since 1995

    IMPROVED

    calming™

    DIAPER RASH
    CREAM
    SKIN PROTECTANT

    FRENCH LAVENDER • ZINC OXIDE
    HELPS TO PREVENT & RELIEVE
    ULTRA-PURIFIED LANOLIN • CONCENTRATED
    NO GLUTEN, SOY, OAT OR DAIRY

    PURE ESSENTIAL OILS
    CLOTH DIAPER SAFE

    ALLERGY
    TESTED

    • for babies • kids •
    • sensitive adults •

    Net Wt. 82 g/2.9 Oz.

    Principal Display Panel - 82 g Tube Label
  • INGREDIENTS AND APPEARANCE
    CALMING DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    glyceryl stearate SE (UNII: FCZ5MH785I)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    glyceryl caprylate (UNII: TM2TZD4G4A)  
    lanolin (UNII: 7EV65EAW6H)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    viola tricolor (UNII: 9Q24RAI43V)  
    coconut oil (UNII: Q9L0O73W7L)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    glycerin (UNII: PDC6A3C0OX)  
    cetyl alcohol (UNII: 936JST6JCN)  
    levulinic acid (UNII: RYX5QG61EI)  
    squalane (UNII: GW89575KF9)  
    lavender oil (UNII: ZBP1YXW0H8)  
    clary sage oil (UNII: 87L0D4U3M0)  
    tea tree oil (UNII: VIF565UC2G)  
    carthamus tinctorius seed oleosomes (UNII: 9S60Q72309)  
    p-anisic acid (UNII: 4SB6Y7DMM3)  
    allantoin (UNII: 344S277G0Z)  
    xanthan gum (UNII: TTV12P4NEE)  
    evening primrose oil (UNII: 3Q9L08K71N)  
    fytic acid (UNII: 7IGF0S7R8I)  
    yucca schidigera root (UNII: E2H9ET15AT)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    stearyl glycyrrhetinate (UNII: 3YYE6VJS0P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-100-2982 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/31/2015
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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