Label: TREEANNSEA ESKIMO MELLA FERTILE SOOTHING TONER- witch hazel cream

  • 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 March 18, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients: Hamamelis Virginiana (Witch Hazel) Water 0.05%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glycerin, Tremella fuciformis polysaccaride, Tremella fuciformis extract, Lavandula Angustifolia (Lavender) Extract, Rubus Idaeus (Raspberry) Fruit Extract, Althaea Officinalis Leaf Extract, Portulaca Oleracea Extract, Citrus Nobilis (Mandarin Orange) Fruit Extract, Gossypium Herbaceum (Cotton) Seed Extract, Fucus Vesiculosus Extract, Morus Nigra Fruit Extract, Mentha Piperita (Peppermint) Extract, Grifola Frondosa Extract, Pueraria lobata root extract, Zanthoxylum piperitum fruit extract/Pullsatilla koreana extract, Usnea barbata extract, Carrageenan, Seratonia siliqua gum, Gellan gum, Cellulose gum, 1,2-hexandiol, Allantoin, Caprylyl glycol, Panthenol, Crinum asiaticum extract, Xanthan gum, Chamomile, Polysorbate 85, Anthemis nobilis flower oil

  • PURPOSE

    Purpose: Skin Protectant

  • Cautions

    Cautions: For external use only. Avoid contact with eyes and mouth. Discountinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    How to use: Apply appropriate amount on the face after cleansing.

  • DOSAGE & ADMINISTRATION

    How to use: Apply appropriate amount on the face after cleansing.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    TREEANNSEA ESKIMO MELLA FERTILE SOOTHING TONER 
    witch hazel cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69515-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel0.1 mg  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69515-030-01200 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2015
    Labeler - PINE TORTE GROUP CO., LTD. (689004693)
    Registrant - PINE TORTE GROUP CO., LTD. (689004693)
    Establishment
    NameAddressID/FEIBusiness Operations
    PINE TORTE GROUP CO., LTD.689004693manufacture(69515-030)
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