SPL v2
SPL
SPL Set ID dbfe8b9e-e343-4ed5-bd81-01b27b4aa912
Route
TOPICAL
Published
Effective Date 2018-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (10 g)
Inactive Ingredients
Aluminum Hydroxide Bentonite Carbomer 940 Diglycerin Monostearate Methylparaben Polyethylene Glycol 600 Potassium Hydroxide Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-20

Description

Active ingredients Benzoyl peroxide  10%


Medication Information

Warnings and Precautions

Warnings

•For external use only

Do not use

•if you have sensitive skin or are sensitive to benzoyl peroxide

When using this product

•avoid contact with eyes, lips and mouth •avoid contact

with hair or dyed fabrics including carpet and clothing which

may be bleached by this product  •with other topical acne

medicaitons, at the same time nor immediately following use

of this product, increased dryness or irritation of the skin

may occur. If this occurs, only one medicaiton should be used

unless directed by a doctor  •skin irritaiton may occur,

characterized by redness, burning, itching, peeling or possibly

swelling. More frequent use or higher concentration may

aggravtae skin irritation. Mild irritation may be reduced by

using the product less frequently or in a lower concentration

•avoid unnecessary sun exposure and use a sunscreen

Stop use and ask a doctor

•if skin irritation becomes severe

Indications and Usage

  for the treatment and prevention of acne pimples Uses

Dosage and Administration

Directions

•cleanse the skin thoroughly before applying medication

•cover the entire affected area with a thin layer one to three

times a day

•because excessive drying of the skin may occur, start with

one applicaiton daily, then gradually increase to two to 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

Description

Active ingredients Benzoyl peroxide  10%

Section 44425-7

  •keep tightly closed Other information

•store at room temperature 68° - 86° F (20° - 30°C).

Section 50565-1

  In case of accidental ingestion, Keep out of reach of children.

get medical help or contact a Poison Control Center immediately.

Section 51727-6

  aluminum hydroxide, bentonite, Inactive ingredients

carbomer, glycerin monostearate, isopropyl myristate,

methylparaben, peg-12, potassium hydroxide, propylene glycol,

propylparaben, water

Section 51945-4

Section 53413-1

  1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1

Purpose

Acne medication

Section 55106-9

Active ingredients

Benzoyl peroxide  10%


Structured Label Content

Indications and Usage (34067-9)

  for the treatment and prevention of acne pimples Uses

Dosage and Administration (34068-7)

Directions

•cleanse the skin thoroughly before applying medication

•cover the entire affected area with a thin layer one to three

times a day

•because excessive drying of the skin may occur, start with

one applicaiton daily, then gradually increase to two to 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

Warnings and Precautions (34071-1)

Warnings

•For external use only

Do not use

•if you have sensitive skin or are sensitive to benzoyl peroxide

When using this product

•avoid contact with eyes, lips and mouth •avoid contact

with hair or dyed fabrics including carpet and clothing which

may be bleached by this product  •with other topical acne

medicaitons, at the same time nor immediately following use

of this product, increased dryness or irritation of the skin

may occur. If this occurs, only one medicaiton should be used

unless directed by a doctor  •skin irritaiton may occur,

characterized by redness, burning, itching, peeling or possibly

swelling. More frequent use or higher concentration may

aggravtae skin irritation. Mild irritation may be reduced by

using the product less frequently or in a lower concentration

•avoid unnecessary sun exposure and use a sunscreen

Stop use and ask a doctor

•if skin irritation becomes severe

Section 44425-7 (44425-7)

  •keep tightly closed Other information

•store at room temperature 68° - 86° F (20° - 30°C).

Section 50565-1 (50565-1)

  In case of accidental ingestion, Keep out of reach of children.

get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

  aluminum hydroxide, bentonite, Inactive ingredients

carbomer, glycerin monostearate, isopropyl myristate,

methylparaben, peg-12, potassium hydroxide, propylene glycol,

propylparaben, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

  1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1 (55105-1)

Purpose

Acne medication

Section 55106-9 (55106-9)

Active ingredients

Benzoyl peroxide  10%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)