Label: YELLOW- shea butter, allantoin lotion

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

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Drug Label Information

Updated July 25, 2017

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  • Active Ingredients

    Shea Butter (11%)

    Allantoin (2%)

  • Purpose

    Skin Protectant

  • Uses

    Moisturizes skin

  • 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

  • Directions

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

  • Inactive Ingredients

    Castor oil, Camellia oil, Emulsifying wax, Distilled Water, Rose water, Glycerin, Vitamin E oil, Optiphen plus, Fruity Fusion Fragrance oil

  • Keep out of reach of children

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

  • Yellow Lotion (Shea Butter Lotion)

    yellow lotion (shea butter lotion)

  • INGREDIENTS AND APPEARANCE
    YELLOW 
    shea butter, allantoin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71547-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.4 g  in 20 mL
    SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER2.2 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71547-110-021 in 1 PACKAGE07/24/2017
    1NDC:71547-110-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/24/2017
    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(71547-110)
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