Label: ORGANIC DIAPER RASH CREAM- zinc oxide cream

  • NDC Code(s): 71330-201-40, 71330-201-90
  • Packager: ALTEYA ORGANICS OOD
  • 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 April 13, 2021

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  • Drug Facts

  • Active Ingredient:

    Non-Nano Zinc Oxide 17%

  • Purpose

    Skin Protectant

  • Use:

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

    For external use only

    • If condition worsens or does not improve within 7 days, consult a physician.
    • ​​​​​When using this product avoid contact with eyes.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
  • Directions:

    • Change wet or soiled diapers promptly. Clean the diaper area and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged.
  • Inactive Ingredients:

    Helianthus Annuus (Sunflower) Seed Oil*, Prunus Armeniaca (Apricot) Kernel Oil*, Cera Alba (Beeswax)*, Garcinia Indica (Kokum) seed Butter*, Cetyl Alcohol, Euphorbia Cerifera (Candelilla Wax) Cera, Copernicia Cerifera (Carnauba Wax) Cera*, Cymbopogon Martini (Palmarosa) Oil*,  Calendula Officinalis (Marigold) Flower Extract*, Hippophae Rhamnoides (Seabuckthorn) Fruit Extract*, Lavandula Angustifolia (Lavender) Oil*, Anthemis Nobilis (Roman Chamomile) Flower Oil*, Rosa Damascena (Rose) Flower Oil*, Tocopherol (Vitamin E), Geraniol**, Linalool**, Citronellol**, Limonene**, Farnesol**, Citral** .

    * Certified Organic Ingredients   ** Naturally occurring in essential oils.

  • Other information:

    • Store at temperatures between 20-25°C/ 68-77°F. Keep away from excessive heat and direct sun. Higher or lower temperatures may cause the product to separate or thicken.
    •  May stain some fabrics.
  • SPL UNCLASSIFIED SECTION

    Soothe, Treat and Prevent

    Non-nano Zinc Oxide

    • Pediatrician Tested
    • Suitable for Sensitive Skin

    CERTIFIED ORGANIC

    www.NATRUE.ORG

    Our Certified Organic Diaper Rash Cream is soothing treatment suitable for sensitive skin. Clinically tested and pediatrician approved,

    it forms a protective barrier to help heal and soothe discomfort caused by diaper rash.

    Not Tested on Animals

    Manufactured by Alteya Organics LLC.

    Yagoda 6167, Made in Bulgaria. www.AlteyaOrganics.com

    Not Tested on Animals

    C/PE/ALU

    NSF contains organic Ingredients

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ORGANIC DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71330-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION17 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    FARNESOL (UNII: EB41QIU6JL)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71330-201-9090 mL in 1 TUBE; Type 0: Not a Combination Product09/16/201704/30/2021
    2NDC:71330-201-4040 mL in 1 CONTAINER; Type 0: Not a Combination Product09/16/201705/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/16/201704/30/2021
    Labeler - ALTEYA ORGANICS OOD (503572407)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALTEYA ORGANICS OOD503572407manufacture(71330-201)
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