ACNE LAB FOAM CLEANSER- salicylic acid liquid

Acne Lab Foam Cleanser by

Drug Labeling and Warnings

Acne Lab Foam Cleanser by is a Otc medication manufactured, distributed, or labeled by AMAROS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Salicylic acid 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Sodium Laureth Sulfate, Sodium Lauroyl Glutamate, Glycerin, Lauric Acid, Myristic Acid, Lauramide DEA, Cocamidopropyl Betain, Cocamide DEA, Potassium Hydroxide, Panthenol, Sodium Chloride, Dryopteris Crassirhizoma Extract, Hamamelis Virginiana (Witch Hazel) Extract, Allantoin, Caprylyl Glycol, Caprylhydroxamic Acid, Rosmarinus Officinalis(Rosemary) Leaf Oil, Beta-Glucan, Citric Acid, Lavandula Angustifolia (Lavender) Oil, Disodium EDTA, Dipotassium Glycyrrhizate.

PURPOSE

Purpose: Cleansing Skin Care for oily, acne skin

WARNINGS

Warnings: 1. In case of having following symptoms after using this product, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children.

INDICATIONS AND USAGE

Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening.

DOSAGE AND ADMINISTRATION

Dosage and Administration: Foam Cleansing helps clear and prevent acne. Wet your face with water. Pump 2 or 3 pumps of foaming cleanser into the palms of your hands. Rub the cleanser gently into your skin in circular motion with fingertips. Wash off the cleanser by splashing water onto your face. Dab face dry with a clean towel.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE LAB FOAM CLEANSER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60899-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic acid	0.75 mg  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60899-080-01	150 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/01/2013

Labeler - AMAROS CO., LTD. (690338801)

Registrant - AMAROS CO., LTD. (690338801)

Establishment
Name	Address	ID/FEI	Business Operations
AMAROS CO., LTD.		690338801	manufacture(60899-080)