RxNorm Names

Review RxNorm Normal Forms

CLEARASIL ULTRA RAPID ACTION TREATMENT (salicylic acid) gel
[Reckitt Benckiser LLC]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c19ea241-9952-4251-bb4d-2db521bead94

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

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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 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 (Salicylic Acid)	Salicylic Acid	2 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water
Polysorbate 20
Sorbitol
Glycerin
Sodium Hydroxide
Helichrysum Italicum Flower
Lavandula Stoechas Flowering Top
Menthol
Edetate Disodium

Packaging
#	Item Code	Package Description
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

Daily Med

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