BPO CREAMY WASH COMPLETE PACK - benzoyl peroxide
Acella Pharmaceuticals, 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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Active Ingredients

BPO 8% Creamy Wash (Benzoyl Peroxide 4%)

BPO 5% Acne Cleansing Bar (Benzoyl Peroxide 5%)

Purpose

Acne Medication

Use

treats acne and helps prevent new acne blemishes from forming.

Warnings (for Wash and Bar)

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. Irritation may be reduced by using the product less frequently or in a lower concentration.
When using this product - skin irritation and dryness is more likely 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 (for Wash and Bar)

wash the affected area once or twice daily
wet face with water
wet cloth with a little water into a full lather
cleanse face with cloth for 10 -20 seconds, avoiding eyes and mucous membranes.
rinse thoroughly and pat dry.
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 15-30C (59-86F).

Inactive Ingredients (for Wash)

carbomer, cetyl alcohol, citric acid, cocamidopropyl betaine, deionized water, imidazolidinyl urea, methylparaben, mineral oil, PEG 14M, potassium chloride, sodium hydroxide, sodium lauryl sulfate.

Inactive Ingredients (for Bar)

EDTA, fragrance, purified water, sodium chloride, sodium palm kernalate, sodium palmate and titanium dioxide.

Questions

1-800-541-4802

Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009

Acne Bar Label

Acne Bar

Creamy Wash Product Label

Creamy Wash Label

Kit Label

Creamy Wash Kit

BPO CREAMY WASH COMPLETE PACK
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42192-110

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:42192-110-03	1 KIT ( KIT) in 1 KIT	None

QUANTITY OF PARTS
Part #	Package Quantity	Total Product Quantity
Part 1	1 CONTAINER	170.1 g
Part 2	2 CONTAINER	42 g

Part 1 of 2

BPO CREAMY WASH
benzoyl peroxide soap

Product Information
Item Code (Source)	NDC:42192-116
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE)	BENZOYL PEROXIDE	4.0 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
COCAMIDOPROPYL BETAINE
WATER
IMIDUREA
METHYLPARABEN
MINERAL OIL
POLYETHYLENE GLYCOL 600000
POTASSIUM CHLORIDE
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	42192-116-06	170.1 g in 1 CONTAINER	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/27/2011

Part 2 of 2

BPO ACNE CLEANSING
benzoyl peroxide soap

Product Information
Item Code (Source)	NDC:42192-114
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE)	BENZOYL PEROXIDE	5 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PALM KERNELATE
SODIUM PALMATE
EDETIC ACID
TITANIUM DIOXIDE
SODIUM CHLORIDE
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	42192-114-05	21 g in 1 CONTAINER	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/27/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/27/2011

Labeler - Acella Pharmaceuticals, LLC (825380939)

Revised: 10/2011 Acella Pharmaceuticals, LLC