Clearasil® Ultra® Overnight Wash

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.

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Clearasil®
Ultra® Overnight Wash

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use as part of your night time regimen
• 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
• 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 occurs, reduce application to once a day or every other day

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, PEG-200 hydrogenated glyceryl palmate, laureth-4, sodium chloride, PEG-7 glyceryl cocoate, polyquaternium-43, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, sodium hydroxide, formic acid, phenoxyethanol, sodium benzoate, D&C red no. 33, FD&C blue no. 1

Questions?

Call 1-866-25-CLEAR (1-866-252-5327). You may also report side effects to this phone number.

Distributed by: Reckitt Benckiser
LLC Parsippany, NJ 07054-0224
Made in France

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: 63824-306
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)
sodium benzoate (UNII: OJ245FE5EU)
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: 63824-306-88	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/28/2012	09/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	09/28/2012	09/02/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 9/2019

Document Id: 7e5ff57d-1c68-4d8c-9447-293d39596ca9

34390-5

Set id: f0347f2b-f409-4cc6-9a2e-f11d2231291b

Version: 2

Effective Time: 20190904