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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55878-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPANEDIOL 
CARBOMER 940 
CAMELLIA OLEIFERA LEAF 
MELALEUCA ALTERNIFOLIA LEAF 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55878-101-1250 mL in 1 TUBE
2NDC:55878-101-1126 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: f6f260e0-3085-4d89-8709-27656c643b41
Set id: efaec56e-21af-4c4e-9e0f-7ff550c3a65b
Version: 3
Effective Time: 20130222
 
Halogent, LLC (DBA Exposed Skin Care)