CLEARASIL  ULTRA RAPID ACTION TREATMENT- salicylic acid gel 
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® Rapid Action Treatment Gel

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Medication

Use

for the treatment of acne

Warnings

For external use only

Flammable keep away from extreme heat or open flame

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

Directions

Other information

Inactive ingredients

Water, Alcohol Denat., Polysorbate 20, Sorbitol, Hydroxyethylcellulose, Glycerin, Sodium Hydroxide, Fragrance, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Menthol, Disodium EDTA

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

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Clearasil®

ULTRA®

Rapid Action
Treatment
Gel

Salicylic Acid 2%
Acne Medication

4
HOURS

Visibly
reduces
pimple size
and redness
in as little
as 4 hours

With Acceladerm®
Technology

1 FL. OZ. (28 g)

Principal Display Panel - 28 g Tube Carton
CLEARASIL   ULTRA RAPID ACTION TREATMENT
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-341
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 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Sorbitol (UNII: 506T60A25R)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Helichrysum Italicum Flower (UNII: P62Y550X24)  
Lavandula Stoechas Flowering Top (UNII: 70759G2U6A)  
Menthol (UNII: L7T10EIP3A)  
Edetate Disodium (UNII: 7FLD91C86K)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-341-01 1 in 1 CARTON
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 08/01/2011
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 11/2012
Document Id: 257f6574-9190-4965-a6d8-b95f8779bd56
Set id: c19ea241-9952-4251-bb4d-2db521bead94
Version: 2
Effective Time: 20121106
 
Reckitt Benckiser LLC