ACNE TREATMENT SERUM- benzoyl peroxide gel

ACNE TREATMENT SERUM by

Drug Labeling and Warnings

ACNE TREATMENT SERUM by is a Otc medication manufactured, distributed, or labeled by Halogent, LLC (DBA Exposed Skin Care) . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

BENZOYL PEROXIDE (3.5% W/W)

PURPOSE

PURPOSE

ACNE TREATMENT

INDICATIONS & USAGE

INDICATIONS FOR THE TREATMENT OF ACNE

WARNINGS

WHEN USING

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

Stop use and ask a doctor if irritation becomes severe

DO NOT USE

DO NOT USE IF YOU

• HAVE VERY SENSITIVE SKIN
• ARE SENSITIVE TO BENZOYL PEROXIDE

ASK DOCTOR/PHARMACIST

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

QUESTIONS

Questions? 1-866-404-7656

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE TREATMENT SERUM 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55878-101
Route of Administration	TOPICAL

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)