Medpura 5% And 10% Benzoyl Peroxide

Medpura 5% And 10% Benzoyl Peroxide
SPL v4
SPL
SPL Set ID 1b051efe-054b-42a0-915a-b87885bd3c54
Route
TOPICAL
Published
Effective Date 2023-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Carbomer 980 Citric Acid Monohydrate Edetate Disodium Glycerin Imidurea Sodium C14-16 Olefin Sulfonate Sodium Hydroxide Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-13

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Drug Facts

Use

for the treatment of acne

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50570-1

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Section 51945-4

Warnings

For external use only

Directions
  • Shake well
  • 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.
  • wet area to be cleansed
  • apply acne wash and gently massage area for 1-2 minutes
  • 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. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Active Ingredient

Benzoyl peroxide 5% 

Benzoyl peroxide 10%

Other Information

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

Inactive Ingredients

Benzoyl peroxide, Carbomer, Citric acid monohydrate, Edetate Disodium, Glycerin,Imidurea, Sodium alpha olefin sulfonate,

Sodium hydroxide, Purified water.

Questions Or Comments?

call toll-free 1-877-225-6999

When Using This Product
  • avoid unnecessary sun exposure and use a sunscreen.
  • avoid contact with eyes, lips, and mouth, eyelids and mucous membranes.
  • 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.

Structured Label Content

Use

for the treatment of acne

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50570-1 (50570-1)

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions
  • Shake well
  • 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.
  • wet area to be cleansed
  • apply acne wash and gently massage area for 1-2 minutes
  • 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. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Active Ingredient (Active ingredient)

Benzoyl peroxide 5% 

Benzoyl peroxide 10%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Benzoyl peroxide, Carbomer, Citric acid monohydrate, Edetate Disodium, Glycerin,Imidurea, Sodium alpha olefin sulfonate,

Sodium hydroxide, Purified water.

Questions Or Comments? (Questions or comments?)

call toll-free 1-877-225-6999

When Using This Product (When using this product)
  • avoid unnecessary sun exposure and use a sunscreen.
  • avoid contact with eyes, lips, and mouth, eyelids and mucous membranes.
  • 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.

Advanced Ingredient Data


Raw Label Data

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