CLEARASIL ULTRA RAPID ACTION TREATMENT- salicylic acid lotion

Clearasil Ultra by

Drug Labeling and Warnings

Clearasil Ultra by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

When using this product

• avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water.
• using other topical acne medications at the same time or immediately following the 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, chest and back

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 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 2 or 3 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

Other information

• store in a cool, dry place

Inactive ingredients

water, butylene glycol, octyldodecanol, steareth-2, cetyl alcohol, steareth-21, dimethicone, polyacrylamide, glycerin, C13-14 isoparaffin, sodium hydroxide, xanthan gum, magnesium aluminum silicate, laureth-7, fragrance, Lavandula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract, titanium dioxide

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

NEW

Clearasil®

ULTRA

Rapid Action
Treatment Lotion

Face, Chest & Back

Salicylic Acid 2% Acne Medication

4
HRS

MAXIMUM STRENGTH

Visibly reduces
pimple size in
as fast as
4 hours

With Acceladerm® Technology
4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL ULTRA   RAPID ACTION TREATMENT
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-314
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butylene glycol (UNII: 3XUS85K0RA)
octyldodecanol (UNII: 461N1O614Y)
cetyl alcohol (UNII: 936JST6JCN)
steareth-21 (UNII: 53J3F32P58)
dimethicone (UNII: 92RU3N3Y1O)
glycerin (UNII: PDC6A3C0OX)
C13-14 isoparaffin (UNII: E4F12ROE70)
sodium hydroxide (UNII: 55X04QC32I)
xanthan gum (UNII: TTV12P4NEE)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
laureth-7 (UNII: Z95S6G8201)
Helichrysum Italicum Flower (UNII: P62Y550X24)
titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-314-01	118 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	11/08/2013

Labeler - Reckitt Benckiser LLC (094405024)