Clearasil ®

Clearasil ®
SPL v4
SPL
SPL Set ID bdb87e60-67a6-4c0e-b0ab-3e238a08269c
Route
TOPICAL
Published
Effective Date 2022-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-06

Description

Drug Facts

Purpose

Acne medication


Medication Information

Purpose

Acne medication

Description

Drug Facts

Use

for the treatment of acne

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifirritation becomes severe

Section 50570-1

Do not useif you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • 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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Questions?

1-866-25-CLEAR (1-866-252-5327).You may also report side effects to this phone number.

Active Ingredient

Benzoyl peroxide 10%

Other Information
  • keep outer box for full product information
  • keep tightly closed
  • store at 20-25 °C (68-77 °F)
Inactive Ingredients

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

When Using This Product
  • 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 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.
  • 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.
Principal Display Panel 28 G Tube Carton

Clearasil ®

STUBBORN ACNE CONTROL

5IN1 SPOT TREATMENT CREAM

Benzoyl Peroxide Acne Medication

FIGHTS

5

STUBBORN

ACNE

PROBLEMS

MAXIMUM STRENGTH

FIGHTS 1. BLOCKED PORES 2. PIMPLE SIZE

3. EXCESS OIL 4. ACNE MARKS 5. BLACKHEADS

Net wt. 1 oz (28 g)


Structured Label Content

Use

for the treatment of acne

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifirritation becomes severe

Section 50570-1 (50570-1)

Do not useif you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Purpose

Acne medication

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • 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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Questions?

1-866-25-CLEAR (1-866-252-5327).You may also report side effects to this phone number.

Active Ingredient (Active ingredient)

Benzoyl peroxide 10%

Other Information (Other information)
  • keep outer box for full product information
  • keep tightly closed
  • store at 20-25 °C (68-77 °F)
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)
  • 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 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.
  • 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.
Principal Display Panel 28 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28 g Tube Carton)

Clearasil ®

STUBBORN ACNE CONTROL

5IN1 SPOT TREATMENT CREAM

Benzoyl Peroxide Acne Medication

FIGHTS

5

STUBBORN

ACNE

PROBLEMS

MAXIMUM STRENGTH

FIGHTS 1. BLOCKED PORES 2. PIMPLE SIZE

3. EXCESS OIL 4. ACNE MARKS 5. BLACKHEADS

Net wt. 1 oz (28 g)


Advanced Ingredient Data


Raw Label Data

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