ACNEFREE SEVERE TERMINATOR MAXIMUM STRENGTH- benzoyl peroxide cream

AcneFree Severe Terminator by

Drug Labeling and Warnings

AcneFree Severe Terminator by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Ei LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 10% w/v

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use if you

• ▪ have sensitive skin
• ▪ are sensitive to benzoyl peroxide

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.
• ▪ rinse right away with water if it gets in eyes
• ▪ 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

skin irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• ▪ clean the skin thoroughly before applying this product
• ▪ cover the entire affected area with a thin layer one to three times daily
• ▪ 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

acrylates/C10-30 alkyl acrylate crosspolymer, benzalkonium chloride, bisabolol, butylene glycol, chamomilla recutita (matricaria) flower extract, ethylhexylglycerin, glycerin, methyl methacrylate/glycol dimethacrylate crosspolymer, methylpropanediol, phenoxyethanol, sea whip extract, sodium benzoate, sodium hydroxide, tetrasodium EDTA, water, zingiber officinale (ginger) root extract.

Questions/comments?

1-800-321-4576

acnefree.com

Principal Display Panel

MAXIMUM

STRENGTH

AcneFree®

SEVERE

PRESCRIPTION GRADE

Acne Spot Treatment

Attacks the source of your breakouts

Also contains

Chamomile, Ginger, and Sea Whip

MAXIMUM STRENGTH

TERMINATOR 10®

Advanced 10% Micro-Benzoyl Peroxide

NET WT. 1 OZ. (28 g)

INGREDIENTS AND APPEARANCE

ACNEFREE SEVERE TERMINATOR  MAXIMUM STRENGTH
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1616
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHAMOMILE (UNII: FGL3685T2X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1616-01	1 in 1 CARTON	09/15/2014
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/15/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	MANUFACTURE(0187-1616)