Label: GREEN- allantoin lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 13, 2017

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  • Active Ingredients

    Allantoin (2%)

  • Purpose

    Skin Protectant

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Uses

    Moisturizes skin. Helps to reduce the wrinkles. Brightening care.

  • Directions

    After cleansing and toning the face, apply the adequate amount on skin.

  • Inactive Ingredients

    Castor oil, Pumpkin seed oil, Grape seed oil, Emulsifying wax, Distilled Water, Lavender water, Glycerin, Vitamin E oil, Optiphen plus

  • Warnings

    For external use only

    Do not use when skin is red, inflamed, irritated, or painful

    When using this product

    - do not apply on other parts of the body

    - avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

    - do not apply directly to wound or open cut

    Stop use and ask a doctor if

    - Rash or irritation on skin develops and lasts

  • Green Lotion (Camellia oil & Pumpkin seed oil)

    Green Lotion (Camellia oil & Pumpkin seed oil)

  • INGREDIENTS AND APPEARANCE
    GREEN 
    allantoin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71547-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.4 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71547-103-021 in 1 PACKAGE07/13/2017
    1NDC:71547-103-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/13/2017
    Labeler - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)
    Registrant - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)
    Establishment
    NameAddressID/FEIBusiness Operations
    Iruri Nature Handmade Soap & Cosmetic Inc095675041manufacture(71547-103)