ClearasilULTRA®

Drug Labeling and Warnings

Drug Details [pdf]

CLEARASIL ULTRA  OVERNIGHT 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.

----------

Clearasil
ULTRA®

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, 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

• wet face
• shake product and dispense onto hand
• massage over face and neck
• rinse thoroughly and dry
• use as part of your night time regime

Other information

• Store in a cool dry place
• Do not store in direct sunlight.

Inactive ingredients

Water, Glycerin, Sodium Laureth Sulfate, Coco-Glucoside, Cocamidopropyl Betaine, Glycol Distearate, Sodium Chloride, PEG-200 Hydrogenated Glyceryl Palmate, Laureth-4, PEG-7 Glyceryl Cocoate, Polyquaternium-43, Fragrance, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Sodium Hydroxide, Formic Acid, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Red 33, Blue 1.

Questions? Comments?

www.clearasil.com

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

Clearasil®

ULTRA®

Overnight
Wash

Salicylic Acid 2% Acne Medication

Helps
visibly reduce
pimple size
and redness
overnight

6.78 FL. OZ. (200 mL)

071511

0349405

CLEARASIL ULTRA   OVERNIGHT WASH
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-338
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)
Glycerin (UNII: PDC6A3C0OX)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
Coco Glucoside (UNII: ICS790225B)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Glycol Distearate (UNII: 13W7MDN21W)
Laureth-4 (UNII: 6HQ855798J)
Sodium Chloride (UNII: 451W47IQ8X)
PEG-7 Glyceryl Cocoate (UNII: VNX7251543)
Helichrysum Italicum Flower (UNII: P62Y550X24)
Sodium Hydroxide (UNII: 55X04QC32I)
Formic Acid (UNII: 0YIW783RG1)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Isobutylparaben (UNII: 0QQJ25X58G)
Propylparaben (UNII: Z8IX2SC1OH)
D&C Red No. 33 (UNII: 9DBA0SBB0L)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-338-01	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2011	09/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	07/23/2011	09/02/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 9/2019

Document Id: ef8c1cde-8376-4859-b60d-070956526c18

34390-5

Set id: 1c9c3e5c-25ab-4f36-84c7-cf75fa839f40

Version: 4

Effective Time: 20190918