BPO 6%- benzoyl peroxide cloth

BPO 6% by

Drug Labeling and Warnings

BPO 6% by is a Otc medication manufactured, distributed, or labeled by Acella Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

6% Benzoyl Peroxide Acne Medication

Drug Facts

Active ingredients

Benzoyl Peroxide 6%

Purpose

Acne Medication

Use

treats acne and helps prevent new acne blemishes from forming.

Warnings

For external use only

Do not use

•  if you have very sensitive skin 
•  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 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. 
• 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.

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.

Directions

• wash the affected area once or twice daily
• wet face with water
• wet cloth with a little water and work into a full lather
• cleanse face with cloth for 10 - 20 seconds, avoiding eyes and mucous membranes.
• rinse thoroughly and pat dry
• discard cloth, do not flush
• If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often
• If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Other Information

Store at controlled room temperature 15° - 30°C (59° - 86°F).

Inactive Ingredients

cetostearyl alcohol, cocamidopropyl betaine, corn starch, deionized water, dimethyl isosorbide, glycerine, glycolic acid, hydrogenated castor oil, imidurea, methylparaben, mineral oil, PEG-14M, potassium chloride, sodium hydroxide, sodium lauryl sulfate, sodium PCA and titanium dioxide.

Questions? 1-800-541-4802

Manufactured by:
Acella Pharmaceuticals, LLC
1-800-541-4802
Rev 1017-02

PRINCIPAL DISPLAY PANEL

NDC: 42192-161-60

BPO 6% Foaming Cloths

6% Benzoyl Peroxide
Acne Medication

Net weight 3.2 g

Acella PHARMACEUTICALS, LLC

NDC: 42192-161-60

BPO 6% Foaming Cloths

6% Benzoyl Peroxide
Acne Medication

60 foaming cloths Net weight 3.2 g each

Acella PHARMACEUTICALS, LLC

INGREDIENTS AND APPEARANCE

BPO 6% 
benzoyl peroxide cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42192-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
STARCH, CORN (UNII: O8232NY3SJ)
WATER (UNII: 059QF0KO0R)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOLIC ACID (UNII: 0WT12SX38S)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42192-161-60	60 in 1 CARTON	06/01/2018
1		1 in 1 PACKET; 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	06/01/2018

Labeler - Acella Pharmaceuticals, LLC (825380939)

Establishment
Name	Address	ID/FEI	Business Operations
Acella Pharmaceuticals, LLC		825380939	MANUFACTURE(42192-161)