FACIAL CLEANSER- salicylic acid gel 
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 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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:55878-105
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM C18 OLEFIN SULFONATE (UNII: Z6CI2A44YH)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55878-105-54 1 in 1 BOX
1 NDC:55878-105-24 120 mL in 1 BOTTLE
2 NDC:55878-105-22 60 mL in 1 BOTTLE
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: 3/2013
Document Id: 2dfe05ea-f794-448c-9a9e-a0645b9765b5
Set id: 62caa4a8-e7b0-4a2e-824b-861652a240ee
Version: 3
Effective Time: 20130313
 
Halogent, LLC (DBA Exposed Skin Care)