CLEARASIL ULTRA ACNE PLUS MARKS SPOT- salicylic acid lotion

Clearasil Ultra by

Drug Labeling and Warnings

Clearasil Ultra by is a Otc medication manufactured, distributed, or labeled by RB Health (US) 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 eyes, lips and mouth. If contact occurs, 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
• Wash hands after use
• Sun Alert: Because this product may make your skin more sensitive to the sun, be certain you have adequate sunscreen protection while using this product and for a week after you discontinue use

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 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.

Other information

• Keep tightly closed
• Store at 20-25°C (68-77°F)

Inactive ingredients

Water, Alcohol Denat., Octyldodecanol, Dimethicone, Niacinamide, Sodium Lactate, Isohexadecane, Polyacrylamide, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Hexyldecanol, C13-14 Isoparaffin, Magnesium Aluminum Silicate, Fragrance, Laureth-7, Disodium EDTA, Dipotassium Glycyrrhizate, Bisabolol, Cetylhydroxyproline Palmitamide, Stearic Acid, Brassica Campestris (Rapeseed) Sterols, Titanium Dioxide

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
Made in USA

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

Clearasil®

ULTRA

Acne + Marks
Spot Lotion
Salicylic Acid 2% Acne Medication

REDUCES
MARKS

Helps to clear
pimples fast
and reduce the
appearance of
acne marks

1 FL. OZ. (30 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL ULTRA   ACNE PLUS MARKS SPOT
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-347
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)
Octyldodecanol (UNII: 461N1O614Y)
Dimethicone (UNII: 92RU3N3Y1O)
Niacinamide (UNII: 25X51I8RD4)
Sodium Lactate (UNII: TU7HW0W0QT)
Isohexadecane (UNII: 918X1OUF1E)
Sodium Hydroxide (UNII: 55X04QC32I)
Xanthan Gum (UNII: TTV12P4NEE)
Hexyldecanol (UNII: 151Z7P1317)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Laureth-7 (UNII: Z95S6G8201)
Edetate Disodium (UNII: 7FLD91C86K)
Levomenol (UNII: 24WE03BX2T)
Stearic Acid (UNII: 4ELV7Z65AP)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-347-01	1 in 1 CARTON	08/01/2011
1		30 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	08/01/2011

Labeler - RB Health (US) LLC (081049410)