RxNorm Names

Review RxNorm Normal Forms

CLEARASIL ULTRA RAPID ACTION PADS (salicylic acid) solution
[Reckitt Benckiser LLC]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=50be95b0-8f27-46f3-81f5-d25aa9b8eee6

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.
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

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 right away.

Directions

clean the skin thoroughly before applying this product
wipe a pad over face and neck to cover the entire affected area with a thin layer 1 to 3 times daily
because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times 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

keep jar lid tightly closed
store in a cool, dry place but do not freeze

Inactive ingredients

water, alcohol denat., glycerin, isoceteth-20, sorbitol, sodium hydroxide, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, 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
MADE IN USA

PRINCIPAL DISPLAY PANEL - 90 Pad Container

Clearasil®

ULTRA®

Rapid Action Pads
Salicylic Acid 2% Acne Medication

4
HOURS

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

90 Pads 3.58 in2 (23.1 cm2)

With Acceladerm®
Technology

071511

Principal Display Panel - 90 Pad Container

CLEARASIL ULTRA RAPID ACTION PADS
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-345
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (Salicylic Acid)	Salicylic Acid	0.03 g

Inactive Ingredients
Ingredient Name	Strength
water
glycerin
isoceteth-20
sorbitol
sodium hydroxide
helichrysum italicum flower
edetate disodium

Product Characteristics
Color		Score
Shape	ROUND (Pad)	Size	231mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:63824-345-01	90 in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/12/2011

Labeler - Reckitt Benckiser LLC (094405024)

Revised: 01/2013

Document Id: a3edcf44-145f-4ed0-9de7-2a7367f4b492

Set id: 50be95b0-8f27-46f3-81f5-d25aa9b8eee6

Version: 3

Effective Time: 20130111

Reckitt Benckiser LLC

Daily Med

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