SPL v1
SPL
SPL Set ID 7a846a58-55d2-4874-8e20-9de8c5c95240
Route
TOPICAL
Published
Effective Date 2017-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (25 mg)
Inactive Ingredients
Water Glycerin Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Cetyl Alcohol Sorbitol Glyceryl Dilaurate Stearyl Alcohol Magnesium Aluminum Silicate Sodium Citrate Silicon Dioxide Sodium Lauryl Sulfate Citric Acid Monohydrate Methylparaben Xanthan Gum Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-06-01

Description

Drug Facts

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Drug Facts

Use
  • For the management of acne
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation becomes severe.

Warnings

For external use only

Directions
  • Clean skin thoroughly before applying this product.
  • Apply a thin layer to affected area one to two times per day.
  • 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.
Active Ingredient

Benzoyl Peroxide 2.5%

Inactive Ingredients

Water, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cetyl Alcohol, Sorbitol, Glyceryl Dilaurate, Stearyl Alcohol, Magnesium Aluminum Silicate, Sodium Citrate, Silica, Sodium Lauryl Sulfate, Citric Acid, Methylparaben, Xanthan Gum, Propylparaben.

Microsponge® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling since all warnings are not included on the inner package.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2014 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and imported components V-31490

CVS ® Quality

Money Back Guarantee

#971014

M050733

FP407

When Using This Product
  • Avoid unnecessary sun exposure and use a sunscreen after using this product.
  • Avoid contact with lips, eyes, or mouth.
  • If product gets into the eyes rinse thoroughly with water.
  • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in lower concentration.
  • Avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Do Not Use This Medication If You
  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Principal Display Panel Tube Label

SKIN+PHARMACY

ADVANCED

ACNE

THERAPY

ACTIVE CLEARING LOTION

with Microsponge
® Technology

2.5% Benzoyl Peroxide

  • clinically proven to kill acne-causing bacteria
  • clinically proven to effectively reduce inflammatory lesions
  • soothing, oil-free formula
  • unclogs pores
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

1 FL OZ (30 mL)

Principal Display Panel Carton Label

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

ACTIVE CLEARING LOTION

with Microsponge
® Technology

2.5% Benzoyl Peroxide

  • clinically proven to kill acne-causing bacteria
  • clinically proven to effectively reduce inflammatory lesions
  • soothing, oil-free formula
  • unclogs pores
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

1 FL OZ (30 mL)


Structured Label Content

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

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation becomes severe.

Purpose

Acne Treatment

Warnings

For external use only

Directions
  • Clean skin thoroughly before applying this product.
  • Apply a thin layer to affected area one to two times per day.
  • 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.
Active Ingredient

Benzoyl Peroxide 2.5%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cetyl Alcohol, Sorbitol, Glyceryl Dilaurate, Stearyl Alcohol, Magnesium Aluminum Silicate, Sodium Citrate, Silica, Sodium Lauryl Sulfate, Citric Acid, Methylparaben, Xanthan Gum, Propylparaben.

Microsponge® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling since all warnings are not included on the inner package.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2014 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and imported components V-31490

CVS ® Quality

Money Back Guarantee

#971014

M050733

FP407

When Using This Product (When using this product)
  • Avoid unnecessary sun exposure and use a sunscreen after using this product.
  • Avoid contact with lips, eyes, or mouth.
  • If product gets into the eyes rinse thoroughly with water.
  • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in lower concentration.
  • Avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Do Not Use This Medication If You (Do not use this medication if you)
  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Principal Display Panel Tube Label (Principal Display Panel - Tube Label)

SKIN+PHARMACY

ADVANCED

ACNE

THERAPY

ACTIVE CLEARING LOTION

with Microsponge
® Technology

2.5% Benzoyl Peroxide

  • clinically proven to kill acne-causing bacteria
  • clinically proven to effectively reduce inflammatory lesions
  • soothing, oil-free formula
  • unclogs pores
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

1 FL OZ (30 mL)

Principal Display Panel Carton Label (Principal Display Panel - Carton Label)

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

ACTIVE CLEARING LOTION

with Microsponge
® Technology

2.5% Benzoyl Peroxide

  • clinically proven to kill acne-causing bacteria
  • clinically proven to effectively reduce inflammatory lesions
  • soothing, oil-free formula
  • unclogs pores
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

1 FL OZ (30 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)