Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d8449adb-9deb-461d-818b-4bb9ac6a23cb
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 Medium-chain Triglycerides Propanediol Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Dimethicone Cyclomethicone 5 Steareth-20 Cyclomethicone 6 Glyceryl Monostearate Peg-100 Stearate Phenoxyethanol Xanthan Gum Cetostearyl Alcohol Bentonite Citric Acid Monohydrate Sodium Citrate Sodium Hydroxide Edetate Disodium Ethylhexylglycerin Allantoin Chamomile Flower Oil Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-05-01

Description

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 2.5%

Uses
  • for the management of acne
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.

Section 50568-5

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.

Section 50570-1

Do not use if you

  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Warnings

For external use only

Directions
  • Clean the skin thoroughly before applying this product.
  • Start with one application daily then gradually increase to 2-3 times daily as needed.
  • If going outside apply sunscreen after using this product.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Avoid storing at extreme temperatures (below 40°F and above 100°F).
Active Ingredient

Benzoyl Peroxide 2.5%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Propanediol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone, Cyclopentasiloxane, Steareth-20, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Xanthan Gum, Cetearyl Alcohol, Bentonite, Citric Acid, Sodium Citrate, Disodium EDTA, Ethylhexylglycerin, Sodium Hydroxide, Allantoin, Chamomilla Recutita (Matricaria) Flower Oil, Panthenol

Microsponge® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling

M050735

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

#971012

FP415

M050735

When Using This Product
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid contact with lips, eyes, or mouth.
  • 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.
Principal Display Panel Carton Label

SKIN+PHARMACY

ADVANCED

ACNE THERAPY

TARGETED TREATMENT WIPES

with Microsponge
® Technology

2.5% Benzoyl Peroxide

  • effectively kills acne-causing bacteria
  • promotes healthier, clearer skin
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

2 packs/10 wipes each ● Total 20 pre-moistened wipes

3.5 x 3 in (8.9 x 7.6 cm)

Principal Display Panel Packet Label

SKIN+PHARMACY

ADVANCED

ACNE THERAPY

TARGETED TREATMENT WIPES

with Microsponge
® Technology

2.5% Benzoyl Peroxide

  • effectively kills acne-causing bacteria
  • promotes healthier, clearer skin
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

10 pre-moistened wipes ● 3.5 x 3 in (8.9 x 7.6 cm)

M050744


Structured Label Content

Uses
  • for the management of acne
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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.

Section 50570-1 (50570-1)

Do not use if you

  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Purpose

Acne Treatment

Warnings

For external use only

Directions
  • Clean the skin thoroughly before applying this product.
  • Start with one application daily then gradually increase to 2-3 times daily as needed.
  • If going outside apply sunscreen after using this product.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Avoid storing at extreme temperatures (below 40°F and above 100°F).
Active Ingredient

Benzoyl Peroxide 2.5%

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Propanediol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone, Cyclopentasiloxane, Steareth-20, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Xanthan Gum, Cetearyl Alcohol, Bentonite, Citric Acid, Sodium Citrate, Disodium EDTA, Ethylhexylglycerin, Sodium Hydroxide, Allantoin, Chamomilla Recutita (Matricaria) Flower Oil, Panthenol

Microsponge® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling

M050735

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

#971012

FP415

M050735

When Using This Product (When using this product)
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid contact with lips, eyes, or mouth.
  • 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.
Principal Display Panel Carton Label (Principal Display Panel - Carton Label)

SKIN+PHARMACY

ADVANCED

ACNE THERAPY

TARGETED TREATMENT WIPES

with Microsponge
® Technology

2.5% Benzoyl Peroxide

  • effectively kills acne-causing bacteria
  • promotes healthier, clearer skin
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

2 packs/10 wipes each ● Total 20 pre-moistened wipes

3.5 x 3 in (8.9 x 7.6 cm)

Principal Display Panel Packet Label (Principal Display Panel - Packet label)

SKIN+PHARMACY

ADVANCED

ACNE THERAPY

TARGETED TREATMENT WIPES

with Microsponge
® Technology

2.5% Benzoyl Peroxide

  • effectively kills acne-causing bacteria
  • promotes healthier, clearer skin
  • fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

10 pre-moistened wipes ● 3.5 x 3 in (8.9 x 7.6 cm)

M050744


Advanced Ingredient Data


Raw Label Data

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