ACNEFREE SEVERE TERMINATOR MAXIMUM STRENGTH- benzoyl peroxide cream 
Bausch Health US LLC

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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Drug Facts

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)

AcneFree Acne Spot Treatment Terminator 10 - 1 oz Carton
ACNEFREE SEVERE TERMINATOR  MAXIMUM STRENGTH
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-1616
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-1616-011 in 1 CARTON09/15/201408/01/2017
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/15/201408/01/2017
Labeler - Bausch Health US LLC (831922468)

Revised: 2/2017
 
Bausch Health US LLC