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Clearasil

Reckitt Benckiser LLC

Clearasil ULTRA Rapid Action Treatment Gel


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Medication

Use

for the treatment of acne

Warnings

For external use only

Flammable keep away from extreme heat or open flame

When using this product

  • Avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water
  • With other topical acne medications, at the same time or immediately following use of this product, may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by your doctor
  • Limit use to the face and neck

Stop use and ask a doctor if skin or eye irritation develops

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

Directions

  • Cleanse the skin thoroughly before applying medication
  • 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 2 or 3 applications 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

Clearasil Other information

  • store in a cool dry place

Inactive ingredients

Water, Alcohol Denat., Polysorbate 20, Sorbitol, Hydroxyethylcellulose, Glycerin, Sodium Hydroxide, Fragrance, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Menthol, Disodium EDTA

Questions?

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

Distributed by:
Reckitt Benckiser LLC
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Clearasil®

ULTRA®

Rapid Action
Treatment
Gel

Salicylic Acid 2%
Acne Medication

4
HOURS

Visibly
reduces
pimple size
and redness
in as little
as 4 hours

With Acceladerm®
Technology

1 FL. OZ. (28 g)

Clearasil

Clearasil

Salicylic Acid GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-341
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Salicylic Acid SALICYLIC ACID 2 g

Inactive Ingredients

Ingredient Name Strength
water
POLYSORBATE 20
sorbitol
GLYCERIN
SODIUM HYDROXIDE
Helichrysum Italicum Flower
Lavandula Stoechas Flowering Top
MENTHOL
EDETATE DISODIUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28 in 1 TUBE
2 NDC:63824-341-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-08-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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