Benzoyl Peroxide by Burel Pharmaceuticals, LLC / Groupe PARIMA Inc. BENZOYL PEROXIDE liquid

Benzoyl Peroxide by

Drug Labeling and Warnings

Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by Burel Pharmaceuticals, LLC, Groupe PARIMA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

benzoyl peroxide USP, 5% or 10%

Purpose

Acne medication

Use

• For the treatment of acne

Warnings:

For external use only.

• Avoid contact with eyes, eyelids, lips and mucous membranes.

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

When using this product

• Avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with eyes, lips, and mouth.
• Avoid contact with hair or dyed fabrics, 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.
• 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

SHAKE WELL.

• Clean the skin thoroughly before applying this product.
• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs,follow the directions stated below.
• One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.
• 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 application to once a day or every other day.
• If going outside, apply sunscreen after using this product.
• Follow directions in the sunscreen labeling.
• If irritation or sensitivity develops stop use of both products and ask a doctor.

Other information

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

Inactive Ingredients

Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.

SPL UNCLASSIFIED SECTION

Questions? Call 1-866-525-0688

Manufactured for:
Burel Pharmaceuticals, LLC
Mason, OH 45040 USA

LA-45408
Rev. 01/22

PRINCIPAL DISPLAY PANEL - 5% 5oz (148 g) Bottle Label

NDC: 35573-453-91

BENZOYL
PEROXIDE
TOPICAL
WASH 5%

FOR TOPICAL USE ONLY

Net Weight 5 oz
(148 g)

burelpharma

PRINCIPAL DISPLAY PANEL - 5% 8oz (237 g) Bottle Label

NDC: 35573-453-08

BENZOYL
PEROXIDE
TOPICAL
WASH 5%

FOR TOPICAL USE ONLY

Net Weight 8 oz
(237 g)

burelpharma

PRINCIPAL DISPLAY PANEL - 10% 5oz (148 g) Bottle Label

NDC: 35573-454-91

BENZOYL
PEROXIDE
TOPICAL
WASH 10%

FOR TOPICAL USE ONLY

Net Weight 5 oz
(148 g)

burelpharma

PRINICIPAL DISPLAY PANEL - 10% 8oz (237 g) Bottle Label

NDC: 35573-454-08

BENZOYL
PEROXIDE
TOPICAL
WASH 10%

FOR TOPICAL USE ONLY

Net Weight 8 oz
(237 g)

burelpharma

 

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35573-453
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
cetyl alcohol (UNII: 936JST6JCN)
DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY)
edetate disodium (UNII: 7FLD91C86K)
glycerin (UNII: PDC6A3C0OX)
laureth-12 (UNII: OAH19558U1)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium coco-sulfate (UNII: 3599J29ANH)
sodium lauroamphoacetate (UNII: SLK428451L)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	white (viscous)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35573-453-91	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2022
2	NDC: 35573-453-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	04/15/2022

BENZOYL PEROXIDE 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35573-454
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
cetyl alcohol (UNII: 936JST6JCN)
DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY)
edetate disodium (UNII: 7FLD91C86K)
glycerin (UNII: PDC6A3C0OX)
laureth-12 (UNII: OAH19558U1)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium coco-sulfate (UNII: 3599J29ANH)
sodium lauroamphoacetate (UNII: SLK428451L)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	white (viscous)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35573-454-91	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2022
2	NDC: 35573-454-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	04/15/2022

Labeler - Burel Pharmaceuticals, LLC (609436204)

Establishment
Name	Address	ID/FEI	Business Operations
Groupe PARIMA Inc.		252437850	label(35573-453, 35573-454) , manufacture(35573-453, 35573-454) , pack(35573-453, 35573-454)