ACNE TREATMENT- benzoyl peroxide gel

Acne Treatment by

Drug Labeling and Warnings

Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Big Lots, Vi-Jon, Remar. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzoyl peroxide 10%

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 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, buring, itching, peeling or posible 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.

Directions

• 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 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 daily 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, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Questions?

1-888-593-0593

Claims

This acne medication contains maximum strength benzoyl peroxide.  Themicronized benzoyl peroxide formula goes to work immediately, releasing the medicine deep into the pore where pimples begin

Adverse Reactions Section

Manufacture for Big Lots by: Vi-Jon, inc.

8515 Page Avenue, St. Louis, MO 63114

Made in the USA with US and foreign components

229.001/229AD

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Persa-Gel 10.

principal display panel

SOUND

BODY

COMPARE TO

CLEAN & CLEAR

PERSA-GEL 10

10% BENZOYL PEROXIDE

ACNE MEDICATION

MAXIMUM STRENGTH

NET WT. 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ACNE TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-229
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50594-229-10	1 in 1 PACKAGE	02/23/2016
1		28 g in 1 TUBE; 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	02/23/2016

Labeler - Big Lots (017885351)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		150931459	manufacture(50594-229)

Establishment
Name	Address	ID/FEI	Business Operations
Remar		938028602	repack(50594-229)