ACNE LAB FOAM CLEANSER- salicylic acid liquid 
AMAROS 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 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

Image of carton

ACNE LAB FOAM CLEANSER 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60899-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic acid0.75 mg  in 150 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60899-080-01150 mL in 1 PACKAGE; Type 0: Not a Combination Product09/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/01/2013
Labeler - AMAROS CO., LTD. (690338801)
Registrant - AMAROS CO., LTD. (690338801)
Establishment
NameAddressID/FEIBusiness Operations
AMAROS CO., LTD.690338801manufacture(60899-080)

Revised: 4/2019
Document Id: e3e8a98a-3de5-4374-9266-2e0b1a180c26
Set id: 0d55692b-23ce-46ec-8cab-e066423f695f
Version: 2
Effective Time: 20190411
 
AMAROS CO., LTD.