SPL v1
SPL
SPL Set ID efb570f0-8edc-4d8d-a62e-7d824a52b2f7
Route
TOPICAL
Published
Effective Date 2017-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 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. Cover the entire affected area with a thin layer one to three times daily.
  • If going outside apply sunscreen after using this product. If irritation occurs, stop using both products and consult a physician.
  • Keep tightly closed Avoid storing at extreme temperature (below 40°F and above 100°F)
Active Ingredient

Benzoyl Peroxide 5%

Inactive Ingredients

Water, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sorbitol, Cetyl Alcohol, 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

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

#971013

M050738

FP408

When Using This Product
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid contact with lips, eyes, or mouth. If product gets into the 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.
Do Not This Medication If You
  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Principal Display Panel Label

SKIN+PHARMACY

ADVANCED

ACNE

THERAPY

SPOT TREATMENT

with Microsponge
® Technology

5% Benzoyl Peroxide

  • clinically proven

    to effectively reduce

    inflammatory lesions
  • effectively kills

    acne-causing bacteria
  • helps reduce irritation
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

0.75 FL OZ (22 mL)

Principal Display Panel Carton Label

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

SPOT TREATMENT

with Microsponge
® Technology

5% Benzoyl Peroxide

  • clinically proven

    to effectively reduce

    inflammatory lesions
  • effectively kills

    acne-causing bacteria
  • helps reduce irritation
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

0.75 FL OZ (22 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. Cover the entire affected area with a thin layer one to three times daily.
  • If going outside apply sunscreen after using this product. If irritation occurs, stop using both products and consult a physician.
  • Keep tightly closed Avoid storing at extreme temperature (below 40°F and above 100°F)
Active Ingredient

Benzoyl Peroxide 5%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sorbitol, Cetyl Alcohol, 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

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

#971013

M050738

FP408

When Using This Product (When using this product)
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid contact with lips, eyes, or mouth. If product gets into the 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.
Do Not This Medication If You (Do not this medication if you)
  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Principal Display Panel Label (Principal Display Panel - Label)

SKIN+PHARMACY

ADVANCED

ACNE

THERAPY

SPOT TREATMENT

with Microsponge
® Technology

5% Benzoyl Peroxide

  • clinically proven

    to effectively reduce

    inflammatory lesions
  • effectively kills

    acne-causing bacteria
  • helps reduce irritation
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

0.75 FL OZ (22 mL)

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

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

SPOT TREATMENT

with Microsponge
® Technology

5% Benzoyl Peroxide

  • clinically proven

    to effectively reduce

    inflammatory lesions
  • effectively kills

    acne-causing bacteria
  • helps reduce irritation
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

0.75 FL OZ (22 mL)


Advanced Ingredient Data


Raw Label Data

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