HEISCLEAN FOR MAN- alcohol gel 
HEISCLEAN.CO.,LTD

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.

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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

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)

Revised: 12/2017
Document Id: 0c1ba3f0-67a6-42cc-b92f-f5142fa9ce17
Set id: 7290b74b-884a-4c8a-ac65-b3da8abf88bb
Version: 2
Effective Time: 20171208
 
HEISCLEAN.CO.,LTD