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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BPO 4% CREAMY WASH COMPLETE PACK

Active Ingredients

BPO 4% 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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42192-110-03	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	08/31/2009	03/31/2017

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL 600000 (UNII: 2126FD486L)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42192-116-06	170.1 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM PALMATE (UNII: S0A6004K3Z)
EDETIC ACID (UNII: 9G34HU7RV0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42192-114-05	21 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	08/31/2009	03/31/2017

Labeler - Acella Pharmaceuticals, LLC (825380939)

Name	Address	ID/FEI	Business Operations
Establishment
Acella Pharmaceuticals, LLC		825380939	manufacture(42192-110)

Revised: 9/2018

Document Id: 808ca50a-c687-4210-9963-ed03a523d006

Set id: 163e65b7-c931-4a89-8f09-d359a0bb3d41

Version: 11

Effective Time: 20180911

Acella Pharmaceuticals, LLC