Label: HEISCLEAN FOR MAN- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 8, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredient: Alcohol 3.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Onsen-Sui, Disodium Laureth Sulfosuccinate, Acrylates/Beheneth-25 Methacrylate Copolymer, Disodium Coco-Glucoside Citrate, Decyl Glucoside, 1,2-Hexanediol, Origanum Vulgare Extract, Cinnamomum Cassia Bark Extract, Sophora Angustifolia Root Extract, Hippophae Rhamnoides Extract, Larix Sibirica Wood Extract, Chrysanthellum Indicum Extract, Rheum Palmatum Root/Stalk Extract, Asarum Sieboldi Root Extract, Quercus Mongolia Leaf Extract, Persicaria Hydropiper Extract, Illicium Verum (Anise) Fruit Extract, Corydalis Turtschaninovii Root Extract, Coptis Japonica Root Extract, Machilus Thunbergii Bark Extract, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Origanum Vulgare Leaf/Flower/Stem Extract, Thymus Vulgaris (Thyme) Extract, Potassium Hydroxide, Panax Ginseng Callus Extract, Propanediol, Polyglyceryl-10 Laurate, Lonicera Japonica (Honeysuckle) Flower Extract, Polyglucuronic Acid, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Chenopodium Album Flower Extract, Lactobacillus/Soybean Ferment Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Portulaca Oleracea Extract, Scutellaria Baicalensis Root Extract, Mentha Piperita (Peppermint) Oil, Menthol, RH-Oligopeptide-1, Chlorhexidine Digluconate

  • PURPOSE

    Purpose: Sanitizer

  • WARNINGS

    Warnings:

    For external use only

    1. Please discontinue use immediately in the event that you experience any of the following side effects from using this product, and consult a dermatologist as the symptoms may get worse with continued use. (a) Adverse skin reactions occur upon its application which may involve red spots, swelling, itchiness, and other skin irritation. (b) The applied part shows signs of any of the symptoms mentioned above after exposure to the direct sunlight.

    2. Do not apply to wounds and the area affected by dermatitis, eczema, and other irritations.

    3. Precautions for handling and storage (a) Always close the cap after each use. (b) Always keep the product out of the reach of infants. (c) Do not store the product in high and low temperatures. It should also be kept out of direct sunlight.

    4. Persists consult your doctor or pharmacist.

  • KEEP OUT OF REACH OF CHILDREN

    Always keep the product out of the reach of infants.

  • Uses

    Uses:

    It is a necessity for men to help to keep it clean and comfortable from the discomfort caused by the moisture and sweat of the male groin.

  • Directions

    Directions:

    Wet your groin areas thoroughly with running water (preferably mild in temperature). Apply a suitable amount (1-3g) evenly to the region and massage gently. Rinse thoroughly in clean, lukewarm water.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    HEISCLEAN FOR MAN 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42979-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol6 g  in 200 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42979-150-01200 g in 1 CARTON; Type 0: Not a Combination Product07/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2015
    Labeler - HEISCLEAN.CO.,LTD (694730019)
    Registrant - HEISCLEAN.CO.,LTD (694730019)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANSOLBIOTECH694455165manufacture(42979-150)