BENZOYL PEROXIDE- benzoyl peroxide liquid 
Perrigo New York Inc

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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Perrigo Benzoyl Peroxide 5% Drug Facts

Active ingredient

Benzoyl peroxide 5%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use

if you

have very 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.
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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

shake well
Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
wet area to be cleansed
apply acne wash and gently massage area for 1-2 minutes
rinse thoroughly and pat dry
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

carbomer homopolymer, citric acid*, edetate disodium, glycerin, imidurea, lauryl methacrylate/glycol dimethacrylate crosspolymer, purified water, sodium C14-16 olefin sulfonate, sodium hydroxide *may contain this ingredient

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Benzoyl Peroxide 5%

Acne Medication Wash

Benzoyl Peroxide 5% Label Image
BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45802-280
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
GLYCERIN 
IMIDUREA 
WATER 
SODIUM C14-16 OLEFIN SULFONATE 
SODIUM HYDROXIDE 
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-280-01142 g in 1 BOTTLE
2NDC:45802-280-34227 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/24/2013
Labeler - Perrigo New York Inc (078846912)

Revised: 1/2013
Document Id: 0d685ec1-1459-415e-8277-2af6b55b893a
Set id: 3146cd53-86b8-4c6f-a07f-66cdeb6cc808
Version: 2
Effective Time: 20130130
 
Perrigo New York Inc