Label: HESOL RIM- salicylic acid gel

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 1, 2010

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  • Drug Facts

    Active Ingredient

    Salicylic Acid                       0.10%
    Niacinamide                       0.20%

  • Purpose

    Hair Tonic

  • Keep out of Reach of Children

    Stop use and ask a doctor if

    - chest pain, rapid heartbeat, faintness, or dizziness occurs
    - your hands or feet swell
    - scalp irritation or redness occurs
    - May be harmful if used when pregnant or breast-feeding
    - Keep out of reach of children if swallowed, get medical help or Poison Control Center right away

  • Indication & Usage

    When using this product

    - do not apply on other parts of the body
    - avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water
    - some people have experienced changes in hair color and/or texture
    - it takes time to regrow hair
    - the amount of hair regrowth is different for each person. This product will not work for everyone.

  • Warnings

    For external use only

    Do not use

    - your scalp is red, inflamed, infected, irritated, or painful

    - you have no family history of hair loss

    - your hair loss is sudden and/or patchy

    - your hair loss is associated with childbirth

    - you do not know the reason for your hair loss

    -you are under 18 years of age. Do not use on babies and children Ask adoctor before use if you have heart disease

  • Dosage & Administration

    - shake well before using product

    - apply an appropriate amount all over scalp every day

    - scrub and massage scalp using hands for helping to absorb product

    Other information

    - before use, read all information on carton and enclosed booklet

    - store at controlled room temperature 1 to 30℃

    - Do not store in hot locations or expose to sunlight

  • Inactive Ingredient

    Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Water, Cocamidopropyl Betaine, Betain, Dimethicone, Laureth-23, Laureth-2

  • Hesol Rim Shampoo

    Ecomine Co Ltd

    Net WT. 10.2 FL OZ (300mL)

    image of carton label

  • INGREDIENTS AND APPEARANCE
    HESOL RIM 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51270-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.3 mL  in 300 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.6 mL  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BETAINE (UNII: 3SCV180C9W)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LAURETH-23 (UNII: N72LMW566G)  
    LAURETH-2 (UNII: D4D38LT1L5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    URTICA DIOICA (UNII: 710FLW4U46)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MENTHOL (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Product Characteristics
    Colorbrown (yellow brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51270-111-021 in 1 BOX
    1NDC:51270-111-01300 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2010
    Labeler - Ecomine Co Ltd (557795691)
    Registrant - Ecomine Co Ltd (557795691)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ecomine Co Ltd557795691manufacture