DailyMed - BENZOYL PEROXIDE liquid

NDC Code(s): 35573-453-08, 35573-453-91, 35573-454-08, 35573-454-91
Packager: Burel Pharmaceuticals, LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated April 24, 2024

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SPL UNCLASSIFIED SECTION
DRUG FACTS

DRUG FACTS
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Active Ingredient
benzoyl peroxide USP, 5% or 10%

benzoyl peroxide USP, 5% or 10%
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Purpose
Acne medication

Acne medication
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Use
For the treatment of acne
- For the treatment of acne
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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 ...
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.

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

Store at controlled room temperature, 15° - 30°C (59° - 86°F)
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Inactive Ingredients
Carbomer interpolymer type A NF, cetyl alcohol NF, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP ...

Carbomer interpolymer type A NF, cetyl alcohol NF, 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.
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SPL UNCLASSIFIED SECTION
Questions? Call 1-866-525-0688 - Manufactured for: Burel Pharmaceuticals, LLC - Mason, OH 45040 USA - Rev. 04/24

Questions? Call 1-866-525-0688

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

Rev. 04/24
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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

NDC 35573-453-91

BENZOYL
PEROXIDE
TOPICAL
WASH 5%

FOR TOPICAL USE ONLY

Net Weight 5 oz
(148 g)

burelpharma

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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

NDC 35573-453-08

BENZOYL
PEROXIDE
TOPICAL
WASH 5%

FOR TOPICAL USE ONLY

Net Weight 8 oz
(237 g)

burelpharma

Close
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

NDC 35573-454-91

BENZOYL
PEROXIDE
TOPICAL
WASH 10%

FOR TOPICAL USE ONLY

Net Weight 5 oz
(148 g)

burelpharma

Close
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

NDC 35573-454-08

BENZOYL
PEROXIDE
TOPICAL
WASH 10%

FOR TOPICAL USE ONLY

Net Weight 8 oz
(237 g)

burelpharma

Close

INGREDIENTS AND APPEARANCE

Product Information

BENZOYL PEROXIDE benzoyl peroxide liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
cetyl alcohol (UNII: 936JST6JCN)
edetate disodium (UNII: 7FLD91C86K)
glycerin (UNII: PDC6A3C0OX)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
cetyl alcohol (UNII: 936JST6JCN)
edetate disodium (UNII: 7FLD91C86K)
glycerin (UNII: PDC6A3C0OX)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	04/15/2022

Labeler - Burel Pharmaceuticals, LLC (609436204)

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

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Published Date (What is this?)	Version	Files
Jul 26, 2024	4 (current)	download
Oct 5, 2023	2	download
Apr 15, 2022	1	download

	RxCUI	RxNorm NAME	RxTTY
1	142034	benzoyl peroxide 10 % Medicated Liquid Soap	PSN
2	142034	benzoyl peroxide 100 MG/ML Medicated Liquid Soap	SCD
3	142034	benzoyl peroxide 10 % Medicated Liquid Soap	SY
4	308696	benzoyl peroxide 5 % Medicated Liquid Soap	PSN
5	308696	benzoyl peroxide 50 MG/ML Medicated Liquid Soap	SCD
6	308696	benzoyl peroxide 5 % Medicated Liquid Soap	SY

Label: BENZOYL PEROXIDE liquid

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Drug Label Information

Do not use if you

When using this product

Keep out of reach of children

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Safety

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	NDC
1	35573-453-08
2	35573-453-91
3	35573-454-08
4	35573-454-91

Label: BENZOYL PEROXIDE liquid

View Package Photos

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use if you

When using this product

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

BENZOYL PEROXIDE liquid

Number of versions: 3

BENZOYL PEROXIDE liquid

BENZOYL PEROXIDE liquid

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BENZOYL PEROXIDE liquid

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.