CLARIFYING MASK- sulfur and resorcinol paste 
Halogent, LLC (DBA Exposed Skin Care)

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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PURPOSE

ACNE TREATMENT

ACTIVE INGRDIENT

SULFUR (3.0%)

RESORCINOL (2.0%)

USE

FOR THE TREATMENT OF ACNE

WARNINGS FOR EXTERNAL USE ONLY

When using this product

Stop use and ask a doctor if

Directions

Use 1 to 2 times per week

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. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POSON CONTROL CENTER RIGHT AWAY.

Questions? 1-866-404-7656

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CLARIFYING MASK 
sulfur resorcinol paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55878-102
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 2/2013
Document Id: 901daf24-fae9-4f3f-bb9f-7a7e65af2af9
Set id: fd395c77-c460-49d5-8056-94c532764d92
Version: 5
Effective Time: 20130213
 
Halogent, LLC (DBA Exposed Skin Care)