CLEARASIL ULTRA RAPID ACTION DAILY FACE WASH- salicylic acid lotion

Clearasil Ultra Rapid Action by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.
• 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.
• limit use to the face and neck

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

Directions

• wet face
• dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area
• cover the entire affected area with a thin layer and rinse thoroughly with warm water 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 occurs, reduce application to once a day or every other day

Other information

• store in a cool, dry place.
• do not freeze.

Inactive ingredients

water, sodium cocoyl isethionate, cetearyl alcohol, glycerin, sodium laureth sulfate, sodium cocoamphoacetate, cocamidopropyl betaine, sodium hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, disodium EDTA, Lavendula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract

Questions?

call 1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 200 mL Tube Label

NEW LOOK

Clearasil®

ULTRA

Rapid Action

Daily Face Wash

Salicylic Acid 2% Acne Medication

MAXIMUM STRENGTH

12
HRS

Visibly
clearer skin
in as fast as
12 hours

6.78 FL. OZ. (200 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL ULTRA RAPID ACTION   DAILY FACE WASH
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-380
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)
Sodium Cocoyl Isethionate (UNII: 518XTE8493)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Glycerin (UNII: PDC6A3C0OX)
Sodium Cocoamphoacetate (UNII: W7Q5E87674)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Disodium (UNII: 7FLD91C86K)
Lavandula Stoechas Flowering Top (UNII: 70759G2U6A)
Helichrysum Italicum Flower (UNII: P62Y550X24)
Cistus Monspeliensis Whole (UNII: T2OG06826L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-380-88	200 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2012
2	NDC: 63824-380-60	20 in 1 CARTON	07/01/2012
2	NDC: 63824-380-30	3 mL in 1 PACKET; 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	07/01/2012

Labeler - Reckitt Benckiser LLC (094405024)