Label: AAPE HAIR AMPOULE- allantoin solution

  • 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 February 20, 2019

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  • ACTIVE INGREDIENT

    Active ingredient: Allantoin 0.5%

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  • INACTIVE INGREDIENT

    Inactive ingredients
    Ampoule I: Human Adipocyte Conditioned Media Extract, Mannitol
    Ampoule II: Water, Polyquaternium-7, Propylene Glycol, Glycerin, 1,2-Hexanediol, Lactic Acid, Niacinamide, Polysorbate 20, Glycyrrhiza Glabra (Licorice) Root Extract, Sophora Angustifolia Root Extract, Glycine Soja (Soybean) Seed Extract, Camellia Sinensis Leaf Extract,
    Angelica Gigas Root Extract, Panax Ginseng Root Extract, Cnidium Officinale Root Extract, Polygonum Multiflorum Root Extract, DISODIUM EDTA

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  • PURPOSE

    Purpose: Skin Protectant

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  • WARNINGS

    Warning:
    1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist.
    1) In case of having problems such as red spots, swelling, itching or irritation during using this product
    2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight.
    2. Do not use it on the part where you have a scar, eczema or dermatitis.
    3. Topical use only

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of infants or children's reach.

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  • INDICATIONS & USAGE

    Indication and usage:
    1. Store in refregerator at or below 6 degrees Celsius.
    2. Do not put it in extremely hot or cold places or where exposed to direct sunlight.

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  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Apply after washing face.
    Gently mix AAPE ampoule I with AAPE ampoule II and apply AAPE to skin several times.
    Once opened and mixed, the formular must be used within 3 hours.
    Single Use Only.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    AAPE HAIR AMPOULE 
    allantoin solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62041-020
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.03 mg  in 6 
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Mannitol (UNII: 3OWL53L36A)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62041-020-01 6 in 1 CARTON; Type 0: Not a Combination Product 08/01/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/01/2014
    Labeler - PROSTEMICS Co., Ltd. (689605919)
    Registrant - PROSTEMICS Co., Ltd. (689605919)
    Establishment
    Name Address ID/FEI Business Operations
    PROSTEMICS Co., Ltd. 689605919 manufacture(62041-020)
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