Clearasil ULTRA® Acne Clearing Gel Wash

Drug Labeling and Warnings

Drug Details [pdf]

CLEARASIL ULTRA  ACNE CLEARING GEL WASH- salicylic acid solution 
RB Health (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Clearasil
ULTRA®
Acne Clearing
Gel Wash

Drug Facts

Active ingredient

Salicylic acid 2.0%

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 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 immediately.

Directions

• Wet face
• Pump 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
• Do not store in direct sunlight.

Inactive ingredients

Water, Sodium Laureth Sulfate, Sorbitol, Cocamidopropyl Betaine, Ammonium Lauryl Sulfate, Sodium Chloride, Sodium Hydroxide, Sodium Cocoamphoacetate, Fragrance, Tetrasodium EDTA, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspelienses Extract, Polyquaternium-43, Magnesium Nitrate, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Methylparaben, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Blue 1.

www.clearasil.com

Questions? Comments?

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

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

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

Dermatologist
Tested

Clearasil
Ultra®

NEW
FORMULA

Acne Clearing
Gel Wash

100%

Fights 100% of acne

2% SALICYLIC ACID ACNE MEDICATION
6.78 FL. OZ. (200 mL)

CLEARASIL ULTRA   ACNE CLEARING GEL WASH
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-328
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-328-01	1 in 1 CARTON	08/20/2009	09/02/2019
1		200 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	08/20/2009	09/02/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 9/2019

Document Id: f7e8af14-a760-41af-8535-709b3b74d194

34390-5

Set id: 1b1c4d59-03de-41e4-b7a0-f64bb4326733

Version: 8

Effective Time: 20190923

 

RB Health (US) LLC