Label: HASOL REVITALIZING SCALP AMPOULE- allantoin liquid

  • 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 July 1, 2013

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredient

    Allantoin 0.50%

    Purpose

    Skin protectant

    Keep out of Reach of Children

    Stop use and ask a doctor if scalp is inflamed, infected, irritated, redness or painful.

    Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

    Indication & Usage

    Directions
    ■ Before use, shake well
    ■ Apply 3~5ml of this product ensuring even distribution and massage the scalp with your fingers for enough absorption.
    ■ Do not need to wash out.

    Warnings

    Warnings

    For external use only

    Do not use  ■ If you use other medications on the scalp.
                      ■ On damaged or broken skin

    When using this product
    ■ Do not apply on other parts of the body
    ■ Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

    Dosage & Administration

    Uses   ■ This product is fortified with nutrients for the hair and scalp, helps to make hair smooth and shine.

    Inactive ingredients

    Water, Mentha piperita (Peppermint) extract, Butylene glycol, Centella asiatica extract, Solanum lycopersicum (Tomato) fruit extract, Glycerin, Beta glucan, Polysorbate 20, Aloe barbadensis leaf extract, PEG-60 hydrogenated castor oil, Trehalose, Vanillyl butyl ether, Chlorphenesin, Rehmannia glutinosa root extract, Cornus officinalis fruit extract, Dioscorea japonica root extract, Alisma plantago aquatica extract, Paeonia suffruticosa root extract, Poria cocos extract, Camellia sinensis leaf extract, Citrus paradisi (Grapefruit) seed extract, Tocopheryl acetate, Algin, Eucalyptus globulus leaf oil, Lavandula angustifolia (Lavender) oil, Lycopene, Citrus limon (Lemon) fruit oil, Disodium EDTA, rh-Polypeptide-1

  • Hasol Revitalizing Scalp Ampoule

    Hasol Revitalizing Scalp Ampoule

    Net WT. 0.35FL OZ(10ml) * 12EA

    image of carton label

  • INGREDIENTS AND APPEARANCE
    HASOL REVITALIZING SCALP AMPOULE  
    allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51270-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    TOMATO (UNII: Z4KHF2C175)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    TREHALOSE (UNII: B8WCK70T7I)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187)  
    DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356)  
    ALISMA PLANTAGO-AQUATICA TOP (UNII: 321GB7FW2H)  
    PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    FU LING (UNII: XH37TWY5O4)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LYCOPENE (UNII: SB0N2N0WV6)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    Colorgray (White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51270-116-0212 in 1 BOX
    1NDC:51270-116-0110 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2013
    Labeler - Ecomine Co Ltd (557795691)
    Registrant - Ecomine Co Ltd (557795691)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ecomine Co Ltd557795691manufacture(51270-116)