Your browser does not support JavaScript! CLEARASIL ULTRA RAPID ACTION TREATMENT (SALICYLIC ACID) GEL [RECKITT BENCKISER LLC]
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CLEARASIL ULTRA RAPID ACTION TREATMENT (salicylic acid) gel
[Reckitt Benckiser LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • Cleanse the skin thoroughly before applying medication
  • Cover the entire affected area with a thin layer one to three times daily
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 applications daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

  • store in a cool dry place

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63824-341
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Polysorbate 20 
Sorbitol 
Glycerin 
Sodium Hydroxide 
Helichrysum Italicum Flower 
Lavandula Stoechas Flowering Top 
Menthol 
Edetate Disodium 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-341-011 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D08/01/2011
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 11/2012
 
Reckitt Benckiser LLC

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