CLEARASIL ULTRA ON-THE-GO RAPID ACTION WIPES- salicylic acid solution

Clearasil Ultra by

Drug Labeling and Warnings

Clearasil Ultra by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each wipe)

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.
• 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.

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

• use in place of a rinse-off cleanser. Gently wipe across face, there is no need to rinse.
• use wipe to cleanse and cover the entire affected area with a thin layer of this product 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

• store in a cool, dry place
• reseal pack to keep wipes moist
• dispose of used wipe in the trash (do not flush)

Inactive ingredients

water, PPG-14 butyl ether, ceteareth-20, cetearyl alcohol, cetearyl isononanoate, phenoxyethanol, glycerin, glyceryl stearate, polysorbate 20, fragrance, ceteareth-12, cetyl palmitate, benzoic acid, disodium EDTA, sodium hydroxide, dehydroacetic acid, BHT

Questions?

Call 1-866-25-CLEAR (1-866-252-5327).
You may also report side effects to this phone number.

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Distributed by: Reckitt Benckiser LLC
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 30 Wipes Pouch Label

NEW

Clearasil®

ULTRA

On-The-Go
Rapid Action Wipes

2% Salicylic Acid Acne Medication

FAST

Starts clearing
pores fast to
fight breakouts
on the go

30 Wipes
4 in2 (10.16 cm2)

8028124
070412

INGREDIENTS AND APPEARANCE

CLEARASIL ULTRA   ON-THE-GO RAPID ACTION WIPES
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-340
Route of Administration	TOPICAL

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)
PPG-14 butyl ether (UNII: R199TJT95T)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl isononanoate (UNII: P5O01U99NI)
phenoxyethanol (UNII: HIE492ZZ3T)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
polysorbate 20 (UNII: 7T1F30V5YH)
ceteareth-12 (UNII: 7V4MR24V5P)
cetyl palmitate (UNII: 5ZA2S6B08X)
benzoic acid (UNII: 8SKN0B0MIM)
edetate disodium (UNII: 7FLD91C86K)
sodium hydroxide (UNII: 55X04QC32I)
dehydroacetic acid (UNII: 2KAG279R6R)
butylated hydroxytoluene (UNII: 1P9D0Z171K)

Product Characteristics
Color	WHITE	Score
Shape	SQUARE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-340-30	86 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	08/24/2012

Labeler - Reckitt Benckiser LLC (094405024)