HES CLEAN FOR WOMAN- alcohol solution

HES CLEAN FOR WOMAN by

Drug Labeling and Warnings

HES CLEAN FOR WOMAN by is a Otc medication manufactured, distributed, or labeled by DOCTOR C&C. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Alcohol 1%

INACTIVE INGREDIENT

Inactive ingredients: Aqua (Hydrogen Ionized Water), Rosa Centifolia Flower Water, Butylene Glycol, Witch Hazel Extract, Lavender Flower/Leaf/Stem Extract, Basil Flower/Leaf Extract, Marshmallow Leaf/Root Extract, Heartleaf Houttuynia Extract, Chamomile Flower Extract, Rosemary Extract, Fennel Leaf Extract, Apple Water, Decyl Glucoside, Indian Lettuce Extract, Corydalis ochotensis Turcz Extract, Whitlow Grass Extract, Goosefoot Flower Extract, Sarcodon Aspratus Extract, Maka Root Extract, Pomegranate Extract, Fig Extract, Mulberry Extract, Ginkgo Extract, Hydroxyethylcellulose, Arginine, 1,2-Hexandiol, Ethanol, Lactic Acid, Soy Isoflavones, Black Cohosh Extracts, Knotweed Root Extract, Kudzu Root Extract, Cnidium Officinale Root Extract, Punica Granatum Extract, Red Clover Flower Extract, Thai Kudzu Root Extract, PEG-40 Hydrogenated Castor Oil, Soapberry Extract, Human Oligopeptide-1, Ascorbic Acid, Pyridoxine HCl, Menthol, Damask Rose Oil

PURPOSE

Purpose: Antifungal

WARNINGS

Warnings:
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

KEEP OUT OF REACH OF CHILDREN:
Keep this product out of reach of infants and young children.

INDICATIONS & USAGE

Indications & usage:
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.

DOSAGE & ADMINISTRATION

Dosage & Administration: 2-3g per use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HES CLEAN FOR WOMAN 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42979-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	Alcohol	1.8 mg  in 180 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42979-140-01	180 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/01/2014

Labeler - DOCTOR C&C (557816136)

Registrant - DOCTOR C&C (557816136)

Establishment
Name	Address	ID/FEI	Business Operations
DOCTOR C&C		557816136	manufacture(42979-140)