Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID bb09fe74-69aa-4a8f-aaff-c333cea74e82
Route
TOPICAL
Published
Effective Date 2017-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (10 g)
Inactive Ingredients
Aluminum Hydroxide Bentonite Glyceryl Stearate Se Isopropyl Myristate Methylparaben Polyethylene Glycol 600 Potassium Hydroxide Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-10-31

Description

Benzoyl Peroxide 10%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl Peroxide 10%

Section 51945-4

CVS Acne Spot Treatment

Maximum Strength

10% Benzoyl Peroxide

uses

For the treatment of acne.

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 application daily, then gradually increase to 2 to 3 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 directions in the sunscreen labeling. if sensitivity develops, discontinue use of both products and cpnsult a doctor.
purpose

Acne treatment

warnings

For external use only.

do Not Use
  • if you have very sensitive skin or are sensitive to Benzoyl Peroxide

active Ingredient

Benzoyl Peroxide 10%

inactive Ingredients

Aluminum hydroxide, Bentonite, Carbomer, Glyceryl Stearate SE, Isopropyl myristate, Methylparaben, PEG-12, Potassium Hydroxide, Propylene Glycol, Propylparaben, Water

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 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, possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
stop 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.


Structured Label Content

Section 51945-4 (51945-4)

CVS Acne Spot Treatment

Maximum Strength

10% Benzoyl Peroxide

uses (Uses)

For the treatment of acne.

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 application daily, then gradually increase to 2 to 3 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 directions in the sunscreen labeling. if sensitivity develops, discontinue use of both products and cpnsult a doctor.
purpose (Purpose)

Acne treatment

warnings (Warnings)

For external use only.

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%

inactive Ingredients (Inactive ingredients)

Aluminum hydroxide, Bentonite, Carbomer, Glyceryl Stearate SE, Isopropyl myristate, Methylparaben, PEG-12, Potassium Hydroxide, Propylene Glycol, Propylparaben, Water

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 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, possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
stop and Ask A Doctor If (Stop 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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)