SPL v2
SPL
SPL Set ID 4a5c9d7a-3a26-408f-bdbd-0a19ad06860f
Route
TOPICAL
Published
Effective Date 2017-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (10 g)
Inactive Ingredients
Water Gluconolactone Glyceryl Monostearate Peg-100 Stearate Glycerin Peg-40 Stearate Cetyl Alcohol Dimethicone Magnesium Aluminum Silicate Xanthan Gum Phenoxyethanol Ammonia Isopropylparaben Butylparaben Isobutylparaben Arginine Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-12-13

Description

Benzoyl Peroxide 10%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 10%

Uses
  • for the treatment of acne
Section 51945-4

Warnings

For external use only

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 og 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, use a sunscreen. Allow product to dry, then follow direction in the sunscreen labeling. If sensitivity develops, discontinue use of both products and consult a doctor.
Do Not Use
  • if you have very sensitive skin or are sensitive to benzoyl peroxide
Active Ingredient

Benzoyl Peroxide 10%

Other Information
  • keep tightly closed
  • keep away from heat
Inactive Ingredients

Water, Gluconolactone, Glyceryl Stearate, PEG-100 Stearate, Glycerin, PEG-40 Stearate, Cetyl Alcohol, Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Phenoxyethanol, Ammonium Hydroxide, Isopropylparabem, Butylparaben, Isobutylparaben, Arginine, Titanium Dioxide.

When Using This Product
  • 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.
  • rinse right away with water if it gets in eyes
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth.
  • avoid contact with hair and 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
Stop Use Adn Ask A Doctor If

skin irritation becomes severe

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • for the treatment of acne
Section 51945-4 (51945-4)

Purpose

Acne Treatment

Warnings

For external use only

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 og 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, use a sunscreen. Allow product to dry, then follow direction in the sunscreen labeling. If sensitivity develops, discontinue use of both products and consult a doctor.
Do Not Use (Do not use)
  • if you have very sensitive skin or are sensitive to benzoyl peroxide
Active Ingredient (Active ingredient)

Benzoyl Peroxide 10%

Other Information (Other information)
  • keep tightly closed
  • keep away from heat
Inactive Ingredients (Inactive ingredients)

Water, Gluconolactone, Glyceryl Stearate, PEG-100 Stearate, Glycerin, PEG-40 Stearate, Cetyl Alcohol, Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Phenoxyethanol, Ammonium Hydroxide, Isopropylparabem, Butylparaben, Isobutylparaben, Arginine, Titanium Dioxide.

When Using This Product (When using this product)
  • 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.
  • rinse right away with water if it gets in eyes
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth.
  • avoid contact with hair and 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
Stop Use Adn Ask A Doctor If (Stop use adn ask a doctor if)

skin irritation becomes severe

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)