ACNE TREATMENT SERUM- benzoyl peroxide 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.

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ACTIVE INGREDIENT

BENZOYL PEROXIDE (3.5% W/W)

PURPOSE

ACNE TREATMENT

INDICATIONS FOR THE TREATMENT OF ACNE

When using this product

Stop use and ask a doctor if irritation becomes severe

DO NOT USE IF YOU

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.

DIRECTIONS

Inactive Ingredients

Water, glycerin, propanediol, carbomer, camellia oleifera leaf extract (green tea extract), melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, ethylhexylglycerin, disodium EDTA, sodium hydroxide.

KEEP OUT OF REACH OF CHILDREN

Questions? 1-866-404-7656

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ACNE TREATMENT SERUM 
benzoyl peroxide gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55878-101
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 3.5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55878-101-12 50 mL in 1 TUBE
2 NDC:55878-101-11 26 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: f6f260e0-3085-4d89-8709-27656c643b41
Set id: efaec56e-21af-4c4e-9e0f-7ff550c3a65b
Version: 3
Effective Time: 20130222
 
Halogent, LLC (DBA Exposed Skin Care)