Label: MADE OF DIAPER RASH CREAM- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 17, 2020

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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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