Benzoyl Peroxide Topical Wash

Benzoyl Peroxide Topical Wash
SPL v4
SPL
SPL Set ID 0617d42d-511d-4c1a-a919-b37abbc14efc
Route
TOPICAL
Published
Effective Date 2024-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cetyl Alcohol Edetate Disodium Glycerin Glyceryl Stearate/peg-100 Stearate Laureth-12 Magnesium Aluminum Silicate Propylene Glycol Water Sodium Coco-sulfate Sodium Lauroamphoacetate Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-15

Description

DRUG FACTS

Purpose

Acne medication


Medication Information

Purpose

Acne medication

Description

DRUG FACTS

Use
  • For the treatment of acne
Section 42229-5

DRUG FACTS

Warnings:

For external use only.

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

benzoyl peroxide USP, 5% or 10%

Do Not Use If You
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information

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

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, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.

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.

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

 

Structured Label Content

Use
  • For the treatment of acne
Section 42229-5 (42229-5)

DRUG FACTS

Purpose

Acne medication

Warnings:

For external use only.

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

benzoyl peroxide USP, 5% or 10%

Do Not Use If You (Do not use if you)
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information (Other information)

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

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, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.

When Using This Product (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 (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel 5% 5oz (148 G) Bottle Label (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 (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 (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 (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

 

Advanced Ingredient Data


Raw Label Data

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