Your browser does not support JavaScript! ACNE TREATMENT SERUM (BENZOYL PEROXIDE) GEL [HALOGENT, LLC (DBA EXPOSED SKIN CARE) ]
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ACNE TREATMENT SERUM (benzoyl peroxide) 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

ACTIVE INGREDIENT

BENZOYL PEROXIDE (3.5% W/W)

PURPOSE

ACNE TREATMENT

INDICATIONS FOR THE TREATMENT OF ACNE

When using this product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if irritation becomes severe

DO NOT USE IF YOU

  • HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE

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

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Best results achieved if applied while skin is still slightly wet from the Exposed Clearing Tonic.
  • 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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

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

ATS_new

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
 
Halogent, LLC (DBA Exposed Skin Care)

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