CLEARASIL ULTRA  RAPID ACTION TREATMENT- salicylic acid lotion 
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 Lotion

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.
  • using other topical acne medications at the same time or immediately following the 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, chest and back

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, butylene glycol, octyldodecanol, steareth-2, cetyl alcohol, steareth-21, dimethicone, polyacrylamide, glycerin, C13-14 isoparaffin, sodium hydroxide, xanthan gum, magnesium aluminum silicate, laureth-7, fragrance, Lavandula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract, titanium dioxide

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 - 118 mL Tube Label

NEW

Clearasil®

ULTRA

Rapid Action
Treatment Lotion

Face, Chest & Back

Salicylic Acid 2% Acne Medication

4
HRS

MAXIMUM STRENGTH

Visibly reduces
pimple size in
as fast as
4 hours

With Acceladerm® Technology
4 FL. OZ. (118 mL)

Principal Display Panel - 118 mL Tube Label
CLEARASIL ULTRA   RAPID ACTION TREATMENT
salicylic acid lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-314
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)  
butylene glycol (UNII: 3XUS85K0RA)  
octyldodecanol (UNII: 461N1O614Y)  
cetyl alcohol (UNII: 936JST6JCN)  
steareth-21 (UNII: 53J3F32P58)  
dimethicone (UNII: 92RU3N3Y1O)  
glycerin (UNII: PDC6A3C0OX)  
C13-14 isoparaffin (UNII: E4F12ROE70)  
sodium hydroxide (UNII: 55X04QC32I)  
xanthan gum (UNII: TTV12P4NEE)  
magnesium aluminum silicate (UNII: 6M3P64V0NC)  
laureth-7 (UNII: Z95S6G8201)  
Helichrysum Italicum Flower (UNII: P62Y550X24)  
titanium dioxide (UNII: 15FIX9V2JP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-314-01 118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 11/08/2013
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 11/2013
Document Id: a3bcc225-f0bc-46ae-a47e-ef4bf3f13ef8
Set id: 21c9cfb6-b94e-48d9-8d9b-b65f1e847e49
Version: 1
Effective Time: 20131113
 
Reckitt Benckiser LLC