CLEARASIL ULTRA 5 IN 1 PADS- salicylic acid solution

Clearasil Ultra by

Drug Labeling and Warnings

Clearasil Ultra by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC, Kleen Test Products Corporation . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Salicylic acid 1.9%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Flammable until dry, 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 face and neck

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 the entire affected area 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 but do not freeze
• keep jar tightly closed

Inactive ingredients

water, alcohol denat, isoceteth-20, Aloe barbadensis leaf juice, sodium hydroxide, triethanolamine, allantoin, fragrance, menthol, disodium EDTA, potassium sorbate, sodium benzoate, citric acid

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
Parsippany, NJ 07054-0224

Package Labeling

NEW

Clearasil®

ULTRA

Salicylic Acid 1.9% Acne Medication

5 IN 1
PADS
FIGHTS 5 ACNE PROBLEMS:

• Blocked pores
• Pimple size
• Excess oil
• Acne marks
• Blackheads

90 Pads
2.10 in 2
(5.34 cm 2)

INGREDIENTS AND APPEARANCE

CLEARASIL ULTRA  5 IN 1 PADS
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-322
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.03 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOCETETH-20 (UNII: O020065R7Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TROLAMINE (UNII: 9O3K93S3TK)
ALLANTOIN (UNII: 344S277G0Z)
MENTHOL (UNII: L7T10EIP3A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-322-90	90 in 1 JAR; Type 0: Not a Combination Product	09/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/01/2014

Labeler - RB Health (US) LLC (081049410)

Establishment
Name	Address	ID/FEI	Business Operations
Kleen Test Products Corporation		168165814	manufacture(63824-322)