Your browser does not support JavaScript! CLARIFYING MASK (SULFUR RESORCINOL) PASTE [HALOGENT, LLC (DBA EXPOSED SKIN CARE) ]
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CLARIFYING MASK (sulfur resorcinol) paste
[Halogent, LLC (DBA Exposed Skin Care) ]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • 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 and ask a doctor if

  • SKIN IRRITATION OCCURS OR GET WORSE

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 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
 
Halogent, LLC (DBA Exposed Skin Care)

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