CLEARASIL ULTRA ACNE CLEARING SCRUB- salicylic acid solution

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 the eyes. If product gets into the eyes rinse thoroughly with water.
• with other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one acne medication should be used unless directed by a doctor.
• limit use to the face and neck.

Stop use and ask 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 immediately.

Directions

• Wet face
• Dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area.
• Rinse thoroughly with warm water and pat dry.
• For best results, use twice daily.

Other information

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

Inactive ingredients

Water, Polyethylene, PPG-15 Stearyl Ether, Glycerin, Stearyl Alcohol, Cetyl Betaine, Distearyldimonium Chloride, Sodium Lauryl Sulfate, Cetyl Alcohol, Alcohol, Steareth-21, Sodium Chloride, Behenyl Alcohol, Synthetic Wax, Steareth-2, Fragrance, Xanthan Gum, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Lauryl Alcohol, Mica, Disodium EDTA, PEG-40 Hydrogenated Castor Oil, BHT, Magnesium Nitrate, Phenoxyethanol, Methylparaben, Methylchloroisothiazolinone, Magnesium Chloride, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Methylisothiazolinone, Ferric Ferrocyanide, Titanium Dioxide, Blue1.

SPL UNCLASSIFIED SECTION

For best before date see tube seal.

www.clearasil.com

Questions? Comments?

Call 1-866-25-CLEAR
(1-866-252-5327)*

SPL UNCLASSIFIED SECTION

Distributed by: Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
Made in USA © RBI 2009

0223412

PRINCIPAL DISPLAY PANEL - 150 mL Label

Dermatologist
Tested

Clearasil
Ultra®

NEW
FORMULA

Acne Clearing
Scrub

100%

Fights 100% of acne

2% SALICYLIC ACID ACNE MEDICATION
5 FL. OZ. (150 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL ULTRA   ACNE CLEARING SCRUB
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-318
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)
High Density Polyethylene (UNII: UG00KM4WR7)
PPG-15 Stearyl Ether (UNII: 1II18XLS1L)
Glycerin (UNII: PDC6A3C0OX)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Cetyl Betaine (UNII: E945X08YA9)
Distearyldimonium Chloride (UNII: OM9573ZX3X)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Cetyl Alcohol (UNII: 936JST6JCN)
Alcohol (UNII: 3K9958V90M)
Steareth-21 (UNII: 53J3F32P58)
Sodium Chloride (UNII: 451W47IQ8X)
Docosanol (UNII: 9G1OE216XY)
Steareth-2 (UNII: V56DFE46J5)
Xanthan Gum (UNII: TTV12P4NEE)
Lauryl Alcohol (UNII: 178A96NLP2)
Mica (UNII: V8A1AW0880)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Magnesium Nitrate (UNII: 77CBG3UN78)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Magnesium Chloride (UNII: 02F3473H9O)
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Isobutylparaben (UNII: 0QQJ25X58G)
Propylparaben (UNII: Z8IX2SC1OH)
Methylisothiazolinone (UNII: 229D0E1QFA)
Ferric Ferrocyanide (UNII: TLE294X33A)
Titanium Dioxide (UNII: 15FIX9V2JP)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-318-01	1 in 1 CARTON	08/18/2009
1		150 mL in 1 BOTTLE; 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	08/18/2009

Labeler - RB Health (US) LLC (081049410)