F X FANTACELL AMPOULE (WITCH HAZEL) SOLUTION [GLHKOREA]

F X FANTACELL AMPOULE (WITCH HAZEL) SOLUTION [GLHKOREA]
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NDC 71081-010-01, 71081-010-02
Set ID f5de7c83-ea46-48f6-bffc-e6519edbda9f
Category HUMAN OTC DRUG LABEL
Packager GLHKOREA
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredient: Hamamelis Virginiana (Witch Hazel) Leaf Extract 0.01%

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Pinus Sylvestris Leaf Extract, Fucoxanthin, Alcohol, Glycerin, Repagermanium, Hypsizygus Marmoreus Extract, Loess Extract, Pinus Densiflora Leaf Extract, Undaria Pinnatifida Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Houttuynia Cordata Extract, Angelica Gigas Root Extract, Cnidium Officinale Root Extract, Atractyloides Japonica Rhizome Extract, Sodium Hyaluronate, Adenosine, Mineral Water, Boswellia Carterii Resin Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Ferox Leaf Extract, Beta-glucan, Morus Alba Bark Extract, Glycine Soja (Soybean) Germ Extract, Caviar Extract, Vitis Vinifera (Grape) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Pyrus Pyrifolia (Pear) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Portulaca Oleracea Extract, Acorus Calamus Root Extract, Lavandula Angustifolia (Lavender) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Arctium Lappa Root Extract, Camellia Sinensis Leaf Extract, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Triethanolamine, Fragrance

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  • PURPOSE

    Purpose: Skin Protectant

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  • WARNINGS

    Warnings: 1. While in use of cosmetics if there is any abnomality like the following you should stop using it. If it is used continuously the symptom would be worse. So, you shall consult a dermatologist. (1) If there are any abnormalities such as redness, swelling, itching, and irritation while using (2) In the case such that the application site would have any abnormality like the above due to the direct sunlight. 2. Please do not use in areas with abnormalities such as wounds, eczema and dermatitis. 3. Storage and Handling Precautions (1) After use. the cap must be closed. two will batdeusi cap. (2) Keep out of the reach of infants and children. (3) Please do not store in the places that are hot or cold and under the direct sunlight.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of infants and children.

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  • INDICATIONS & USAGE

    Indications & usage: 1. Please spray an F-X Fantacell Solution Ampoule by using the exclusive spray device (Airbrush Compressor) 2. Fill an Airbrush with a half bottle of an F-X Fantacell Solution Ampoule each time and spray it directly to the body parts such as face, neck, hands, feet, full body and etc.

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  • DOSAGE & ADMINISTRATION

    Dosage & Administration: The amount to use is recommended to be once per two days. Or you may add or reduce some of the amount to use depending on skin conditions. (1) After clearing makeup and washing the face, please gently spray in the face. (2) You may use it gently spraying in the face in a state with makeup. (3) It would be better if the ampoule is used after cleansing the face before bed. (4) It would take 5~10 minutes to spray a half bottle of the ampoule on the face.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    F X FANTACELL AMPOULE 
    witch hazel solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71081-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel 0.8 mg  in 8 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71081-010-02 16 in 1 CARTON 10/01/2016
    1 NDC:71081-010-01 8 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 10/01/2016
    Labeler - GLHKOREA (689851980)
    Registrant - GLHKOREA (689851980)
    Establishment
    Name Address ID/FEI Business Operations
    GLHKOREA 689851980 manufacture(71081-010)
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