Your browser does not support JavaScript! FACIAL CLEANSER (SALICYLIC ACID) GEL [HALOGENT, LLC (DBA EXPOSED SKIN CARE) ]
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FACIAL CLEANSER (salicylic acid) gel
[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 INGREDIENT

SALICYLIC ACID (0.5%)

WARNINGS FOR EXTERNAL USE ONLY

USE

FOR THE TREATMENT OF ACNE

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

Directions

Wet your face and gently massage facial cleanser into skin for 10 - 15 seconds, avoiding contact with eyes. Thoroughly rinse your face with lukewarm water.

  • Wash the entire affected area one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water, cocamidopropyl betaine, sodium olefin sulfonate, acrylate copolymer, triethanolamine, propylene glycol, polyquaternium-7, panthenol, phenoxyethanol, disodium EDTA, salvia officinalis (sage) leaf extract, citric acid, fragrance.

Questions?

1-866-404-7656 or www.exposedskincare.com

FC_newRetail_FC

FACIAL CLEANSER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55878-105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCAMIDOPROPYL BETAINE 
SODIUM C18 OLEFIN SULFONATE 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
TROLAMINE 
PROPYLENE GLYCOL 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) 
PANTHENOL 
PHENOXYETHANOL 
EDETATE DISODIUM 
SALVIA OFFICINALIS FLOWERING TOP 
ANHYDROUS CITRIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55878-105-541 in 1 BOX
1NDC:55878-105-24120 mL in 1 BOTTLE
2NDC:55878-105-2260 mL in 1 BOTTLE
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: 3/2013
 
Halogent, LLC (DBA Exposed Skin Care)

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