Label: HEISCLEAN FOR WOMAN- 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 1.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Rose Extract, Onsen-Sui, Decyl Glucoside, 1,2-Hexanediol, Hamamelis Virginiana (Witch Hazel) Extract, Hydroxyethylcellulose, Arginine, Lactic Acid, Polyglyceryl-4 Caprate, Salicornia Herbacea Extract, Phragmites Communis Extract, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Chenopodium Album Flower Extract, Punica Granatum Fruit Extract, Ficus Carica (Fig) Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Soy Isoflavones, Cimicifuga Racemosa Root, Polygonum Cuspidatum Root Extract, Pueraria Lobata Root Extract, Angelica Polymorpha Sinensis Root Extract, Punica Granatum Extract, Trifolium Pratense (Clover) Flower Extract, Pueraria Mirifica Root Extract, Butylene Glycol, 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, Pyridoxine HCl, Rosa Damascena Flower Oil, Sapindus Mukurossi Fruit Extract, RH-Oligopeptide-1, Disodium EDTA, Menthol

  • 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. Vulvar Cleanser (a) It should only be used on the vulva. (b) It should not be used for long periods of time. (c) It should be used with extreme caution when there are affected areas on the (vulvar) skin or the surrounding area has become contaminated. (d) It should not be used on children under 3 years of age. (e) It is not recommended for use during pregnancy and it is advised that you discontinue its use on the vulva until you deliver a baby as it may get into the eyes of the newborn baby.

  • KEEP OUT OF REACH OF CHILDREN

    Always keep the product out of the reach of infants.

  • Uses

    Uses:

    It keeps women's sensitive and precious area safe and fresh by relaxing the unpleasant smell of women.

  • Directions

    Directions:

    Wet your vulva thoroughly with running water (preferably mild in temperature). Apply a suitable amount (2-3g) 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 WOMAN 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42979-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol2 g  in 200 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Witch Hazel (UNII: 101I4J0U34)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42979-160-01200 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(42979-160)