Label: CALMING DIAPER RASH- zinc oxide cream

  • NDC Code(s): 52915-069-05, 52915-069-29
  • Packager: ORGANIC & SUSTAINABLE BEAUTY
  • 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 6, 2020

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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

    Glyceryl starch, caprylic/capric triglyceride, lanolin, glyceryl stearate, cetearyl alcohol, glyceryl caprylate, cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, stearyl glycyrrhetinate (licorice), lavandula angustifolia (lavender) oil, melaleuca alternifolia (tea tree) leaf oil.

  • PRINCIPAL DISPLAY PANEL - 82 g Tube Label

    CALIF♥RNIA BABY®

    TRUSTED
    SINCE 1995

    therapeutic relief™

    CALMING
    DIAPER RASH
    OINTMENT
    SKIN PROTECTANT

    PRESERVATIVE FREE

    USDA Certified Biobased
    Product 100%

    TREATS, PREVENTS & PROTECTS
    FRENCH LAVENDER

    BABIES + KIDS + ADULTS

    ALLERGY
    TESTED

    © 2019

    NET WT 82 g/2.9 oz.

    USDA
    CERTIFIED
    BIOBASED
    PRODUCT
    PRODUCT 100%

    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:52915-069
    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
    DIMETHYLIMIDAZOLIDINONE RICE STARCH (UNII: 43YT4X3R70)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    lanolin (UNII: 7EV65EAW6H)  
    glyceryl stearate SE (UNII: FCZ5MH785I)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    stearyl glycyrrhetinate (UNII: 3YYE6VJS0P)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-069-2982 g in 1 TUBE; Type 0: Not a Combination Product08/31/2015
    2NDC:52915-069-0514 g in 1 TUBE; Type 0: Not a Combination Product08/31/2015
    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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