Clearasil Ultra® Acne+Marks Wash and Mask

Drug Labeling and Warnings

Drug Details [pdf]

CLEARASIL ULTRA  ACNE PLUS MARKS WASH AND MASK- 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+Marks Wash and Mask

Drug Facts

Active Ingredient

2% Salicylic Acid

Purpose

Acne medication

Use

For the treatment of acne

Warnings

For external use only

When using this product

• avoid contact with 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, may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by your 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

• As a daily wash - wet face. Dispense product into hands, lather and massage gently into face and neck, avoiding the eye area.
• 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 directed by a doctor. If bothersome dryness or peeling occurs, reduce the application to once a day or every other day.
• Rinse thoroughly with warm water and gently pat dry. For best results, use twice daily.
• As a mask – use up to 3 times a week for a deeper treatment – wet fact, 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, Sodium Cocoyl Isethionate, Cetearyl Alcohol, Laureth-3, Glycerin, Coconut Acid, Sodium Isethionate, Sodium Hydroxide, Fragrance, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Disodium EDTA, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben

www.clearasil.com

Questions? Comments?

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

Distributed by:
Reckitt Benckiser Inc. Parsippany,
NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

Dermatologist
Tested

Clearasil
ULTRA®

Acne+Marks
Wash and Mask

FIGHTS FORMATION OF
MARKS

Helps clear pimples fast and
fights the formation of marks

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

CLEARASIL ULTRA   ACNE PLUS MARKS WASH AND MASK
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-346
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)
Laureth-3 (UNII: F32E4CB0UJ)
Glycerin (UNII: PDC6A3C0OX)
Coconut Acid (UNII: 40U37V505D)
Sodium Isethionate (UNII: 3R36J71C17)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Disodium (UNII: 7FLD91C86K)
Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Isobutylparaben (UNII: 0QQJ25X58G)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-346-01	1 in 1 CARTON	10/15/2010	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	10/15/2010	09/02/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 9/2019

Document Id: e0ac8938-2882-4839-b78f-34325172164c

34390-5

Set id: 6bc31db6-2102-4dcc-baeb-c49a57dc06f5

Version: 2

Effective Time: 20190918

 

RB Health (US) LLC