CLARIFYING MASK- sulfur resorcinol paste

CLARIFYING MASK by

Drug Labeling and Warnings

CLARIFYING MASK by is a Otc medication manufactured, distributed, or labeled by Halogent, LLC (DBA Exposed Skin Care) . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

PURPOSE

ACNE TREATMENT

ACTIVE INGREDIENT

ACTIVE INGRDIENT

SULFUR (3.0%)

RESORCINOL (2.0%)

INDICATIONS & USAGE

USE

FOR THE TREATMENT OF ACNE

WARNINGS

WARNINGS FOR EXTERNAL USE ONLY

WHEN USING

When using this product

• using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation. If this occurs, only one medication should be used unless directed by a doctor
• apply only to areas with acne
• do not get into eyes
• do not use on broken skin or large areas of the skin

STOP USE

Stop use and ask a doctor if

• SKIN IRRITATION OCCURS OR GET WORSE

DOSAGE & ADMINISTRATION

Directions

Use 1 to 2 times per week

• Clean the skin thoroughly before applying this product
• Cover the entire affected area with a thin layer, leave on skin for 10-15 minutes, then rinse thoroughly with luke warm water, pat dry skin
• Follow with a small amount of Clearing Tonic applied using bare hands.
• If bothersome dryness or peeling occurs, reduce application to once per week.

INACTIVE INGREDIENT

Inactive Ingredients

Water, kaolin, bentonite, glyceryl stearate, peg-100 stearate, sesame oil, aluminum magnesium silicate, polysorbate 20, caprylyl glycol, phenoxyethanol, sorbic acid, aloe barbadensis leaf extract, vaccinium myrtillus extract, macrocystis pyriferae extract, carbomer, hydroxyethylcellulose, imidazolidinyl urea, caprylic/capric triglycerides, jojoba esters, helianthus annuus (sunflower) seed oil, hydrogenated polydecene, sodium polyacrylate, thioctic acid, dimethylethanolamine, ceramide 3, hyaluronic acid, collagen, retinyl palmitate.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POSON CONTROL CENTER RIGHT AWAY.

QUESTIONS

Questions? 1-866-404-7656

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLARIFYING MASK 
sulfur resorcinol paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55878-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g  in 100 mL
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
BENTONITE (UNII: A3N5ZCN45C)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SESAME OIL (UNII: QX10HYY4QV)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VACCINIUM MYRTILLUS WHOLE (UNII: EE76EZ4QNZ)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
CARBOMER 940 (UNII: 4Q93RCW27E)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
IMIDUREA (UNII: M629807ATL)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
THIOCTIC ACID, (+)- (UNII: VLL71EBS9Z)
DEANOL (UNII: 2N6K9DRA24)
CERAMIDE 3 (UNII: 4370DF050B)
HYALURONIC ACID (UNII: S270N0TRQY)
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55878-102-12	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/07/2013

Labeler - Halogent, LLC (DBA Exposed Skin Care) (790961697)