CLEARASIL ULTRA ACNE PLUS MARKS WASH AND MASK- 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]

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

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

• As a daily wash - wet face. Dispense product into hands, lather and massage gently onto face and neck, avoiding the eye area
• rinse thoroughly with warm water and gently pat dry.
• 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 the application to once a day or every other day.
• As a mask - use up to 3 times a week for a deeper treatment – wet face, apply on to damp skin. Leave on for 1 minute. Rinse off thoroughly with warm water. Gently pat dry.

Other information

• keep tightly closed
• store in a cool, dry place

Inactive ingredients

water, bentonite, kaolin, glycerin, titanium dioxide, sodium laureth sulfate, niacinamide, sodium lactate, xanthan gum, coco-glucoside, cocamidopropyl betaine, hexyldecanol, sodium hydroxide, fragrance, dipotassium glycyrrhizate, disodium EDTA, bisabolol, cetylhydroxyproline palmitamide, stearic acid, Brassica campestris sterols, FD&C blue no. 1, FD&C yellow no. 6

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
Parsippany, NJ 07054-0224
Made in USA

PRINCIPAL DISPLAY PANEL - 200 mL Tube Label

Clearasil®

ULTRA

Acne + Marks
Wash and Mask
Salicylic Acid 2% Acne Medication

REDUCES
MARKS

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

6.78 FL OZ (200 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL ULTRA   ACNE PLUS MARKS WASH AND MASK
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-390
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)
Bentonite (UNII: A3N5ZCN45C)
Kaolin (UNII: 24H4NWX5CO)
Glycerin (UNII: PDC6A3C0OX)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Niacinamide (UNII: 25X51I8RD4)
Sodium Lactate (UNII: TU7HW0W0QT)
Xanthan Gum (UNII: TTV12P4NEE)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Hexyldecanol (UNII: 151Z7P1317)
Sodium Hydroxide (UNII: 55X04QC32I)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Edetate Disodium (UNII: 7FLD91C86K)
Levomenol (UNII: 24WE03BX2T)
Cetylhydroxyproline Palmitamide (UNII: 74ONU0S62G)
Stearic Acid (UNII: 4ELV7Z65AP)
Rapeseed Sterol (UNII: B46B6DD20U)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Yellow No. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-390-88	200 mL in 1 TUBE; Type 0: Not a Combination Product	09/15/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	09/15/2011

Labeler - Reckitt Benckiser LLC (094405024)