CLEARASIL ULTRA 5 IN 1- salicylic acid solution

Clearasil by

Drug Labeling and Warnings

Clearasil 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 2.0%

Purpose

Acne medication

Use

• for the treatment of acne
• helps prevent new acne pimples from forming

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 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. In case of accidental ingestion, 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

• 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?

1-866-252-5327.

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Distributed by:
Reckitt Benckiser
Parsippany, NJ
07054-0224
Made in USA

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

Clearasil®

ULTRA

Salicylic Acid 2.0% Acne Medication

5
IN 1
LOTION
FIGHTS 5 ACNE
PROBLEMS

• Blocked pores
• Pimple size
• Excess oil
• Acne marks
• Blackheads

3.38 FL. OZ. (100 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL   ULTRA 5 IN 1
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-419
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)
steareth-2 (UNII: V56DFE46J5)
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: 63824-419-01	100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/01/2015

Labeler - Reckitt Benckiser LLC (094405024)