MADE OF DIAPER RASH CREAM (ZINC OXIDE) CREAM [MADEOF, LLC]

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MADE OF DIAPER RASH CREAM (ZINC OXIDE) CREAM [MADEOF, LLC]
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NDC 71439-040-15
Set ID 5876e61c-12d6-2313-e053-2a91aa0ab75a
Category HUMAN OTC DRUG LABEL
Packager MADEOF, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    USP Zinc Oxide 14%

  • Purpose

    Skin Protectant

  • Uses

    • Helps prevent and treat diaper rash
    • Protects chafed skin due to diaper rash
    • Helps seal out wetness
  • Warnings

    For external use only

    When using this product

    avoid contact with eyes.

    Stop use and ask a doctor if

    condition worsens, symptoms last more than 7 days or clear up and return 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 or soiled diapers promptly
    • Clean the diaper area
    • Allow to dry
    • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Ingredients

    1Helianthus Annus* (Sunflower) Seed Oil, Cera Alba* (Beeswax), Cocos Nucifera* (Coconut) Oil, Olea Europaea' (Olive) Fruit Oil, Simmondsia Chinensis* (Jojoba) Oil, Butyrospermum Parkii* (Shea) Butter, Lavendula Angustilolia* (Lavender) Oil, Persea Grattisima*(Avocado) Oil, Argania Spinosa* (Argan) Oil, Tocopherol*

    .

    1
    = Certified Organic
  • PRINCIPAL DISPLAY PANEL - 100.55 ml Box and Tube Label

    made of ®

    Diaper Rash Cream

    85% Certified Organic Ingredients

    15% Natural

    NSF
    EWG VERIFIED
    Non GMO

    Nut Free

    Soy Free

    Dermatologist Tested

    Pediatrician Tested

    3.4 fl.oz (100.55ml)

    Diaper Rash Tube

    Diaper Rash box

  • INGREDIENTS AND APPEARANCE
    MADE OF DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71439-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71439-040-151 in 1 CARTON09/05/2017
    1100.55 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/05/2017
    Labeler - MADEOF, LLC (080635957)
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