Clearasil Stubborn Acne Control 5in1 Spot Treatment Cream
FDA Label NDC 63824-438

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Clearasil Stubborn Acne Control 5in1 Spot Treatment (NDC 63824-438). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed By:
Reckitt Benckiser,
Parsippany, NJ 07054-0224

Made in USA

Active Ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Otc - Do Not Use

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

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.

Otc - Stop Use

Stop use and ask a doctor if irritation becomes severe

Otc - 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.

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.

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

Questions?

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

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)

Principal Display Panel (28 g Tube Carton)

Principal Display Panel (28 g Tube Carton)

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