BPO- benzoyl peroxide gel

BPO by

Drug Labeling and Warnings

BPO by is a Otc medication manufactured, distributed, or labeled by Acella Pharmaceuticals, LLC, Ei Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzoyl Peroxide 4%

Purpose

Acne Medication

INDICATIONS & USAGE

Use treats acne and helps prevent new acne blemishes from forming

Keep out of reach of children.

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

For External Use onlyDo not use if you have very sensitive skin or if you are sensitive to benzoyl peroxide

When using this product

• avoid unnecessary sun exposure and use sunscreen

• keep away from eyes, lips and mouth

• avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by 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.

• skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate such irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.

Direction

• 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 nay occur, start with one application daily, then gradually increase to two or three times dailyif needed or as directed by a doctor

• if bothersome dryness or peeling ocurs, reduce application to once a day or every other day

• if going outside, apply sunscreen after using this product. If irritation or sensitivity develpos, discontinue use of product and consult a doctor

Inactive Ingredients

aloe barbadebsis leaf juice, benzyl alcohol, ceteareth-20, cetyl alcohol, dimethyl isisirbide, purified water, simethicone and stearyl alcohol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BPO  
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42192-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	4 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
CETYL ALCOHOL (UNII: 936JST6JCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42192-105-16	12 in 1 PACKAGE
1		1 in 1 CARTON
1		42500 mg in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	01/01/2009

Labeler - Acella Pharmaceuticals, LLC (825380939)

Registrant - Ei Inc. (105803274)

Establishment
Name	Address	ID/FEI	Business Operations
Ei Inc.		105803274	manufacture(42192-105) , label(42192-105) , pack(42192-105)