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.

----------

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

CM_new

CLARIFYING MASK 
sulfur resorcinol paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55878-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR3 g  in 100 mL
RESORCINOL (RESORCINOL) RESORCINOL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
KAOLIN 
BENTONITE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
SESAME OIL 
MAGNESIUM ALUMINUM SILICATE 
POLYSORBATE 20 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
SORBIC ACID 
ALOE VERA LEAF 
VACCINIUM MYRTILLUS WHOLE 
MACROCYSTIS PYRIFERA 
CARBOMER 940 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
IMIDUREA 
MEDIUM-CHAIN TRIGLYCERIDES 
JOJOBA OIL 
SUNFLOWER OIL 
HYDROGENATED POLYDECENE (550 MW) 
SODIUM POLYACRYLATE (8000 MW) 
THIOCTIC ACID, (+)- 
DEANOL 
CERAMIDE 3 
HYALURONIC ACID 
COLLAGEN, SOLUBLE, FISH SKIN 
VITAMIN A PALMITATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55878-102-1250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/07/2013
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)