BENZOYL PEROXIDE- benzoyl peroxide liquid 
Burel Pharmaceuticals, LLC

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BENZOYL PEROXIDE TOPICAL WASH

DRUG FACTS

Active Ingredient

benzoyl peroxide USP, 5% or 10%

Purpose

Acne medication

Use

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 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.

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.

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

5oz 5%

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

5% 8oz

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

10% 5oz

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

 
10% 8oz
BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35573-453
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (viscous) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35573-453-91148 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
2NDC:35573-453-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00604/15/2022
BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35573-454
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (viscous) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35573-454-91148 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
2NDC:35573-454-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00604/15/2022
Labeler - Burel Pharmaceuticals, LLC (609436204)
Establishment
NameAddressID/FEIBusiness Operations
Groupe PARIMA Inc.252437850label(35573-453, 35573-454) , manufacture(35573-453, 35573-454) , pack(35573-453, 35573-454)

Revised: 1/2022
Document Id: 5d41ef57-c955-4158-bb9f-6f25111d7b4b
Set id: 0617d42d-511d-4c1a-a919-b37abbc14efc
Version: 2
Effective Time: 20220107
 
Burel Pharmaceuticals, LLC