CLEARASIL  ULTRA OVERNIGHT WASH- salicylic acid solution 
Reckitt Benckiser 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

Other information

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

Principal Display Panel - 200 mL Bottle Label
CLEARASIL   ULTRA OVERNIGHT WASH
salicylic acid solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-306
Route of Administration TOPICAL DEA Schedule     
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 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
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 09/28/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 10/2012
Document Id: 822e3327-d4dd-47f3-91e6-173a83e711e9
Set id: f0347f2b-f409-4cc6-9a2e-f11d2231291b
Version: 1
Effective Time: 20121004
 
Reckitt Benckiser LLC