CLEARASIL ULTRA RAPID ACTION SEAL-TO-CLEAR- salicylic acid gel

Clearasil Ultra by

Drug Labeling and Warnings

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

Drug Details [pdf]

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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 open fire or flame

When using this product

• Avoid contact with the eyes, lips and mouth. 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, increased dryness or irritation of the skin may occur. If this occurs, only one acne medication should be used unless directed by your doctor
• Limit use to the face and neck
• Wash hands after use

Stop use and ask a doctor if skin or eye irritation develops.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• Cleanse the skin thoroughly, as needed, before applying medication
• Cover the affected area with a thin layer one to three times a day and allow to dry
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 tightly closed
• Store in a cool, dry place
• Cap may pose choking hazard

Inactive ingredients

Water, Alcohol Denat., Sodium Gluconate, Propylene Glycol, Hydroxyethylcellulose, Isoceteth-20, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Sodium Benzoate, Oryza Sativa (Rice) Extract.

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 - 12 mL Tube Label

Clearasil®

ULTRA®

Rapid Action
Seal-to-Clear® Gel
Salicylic Acid 2% Acne Medication

4
HOURS

Seals your
pimple and
visibly reduces
its size and
redness in
4 hours

With Invisa Skin®

0.42 FL. OZ. (12 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL ULTRA   RAPID ACTION SEAL-TO-CLEAR
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-353
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)
Sodium Gluconate (UNII: R6Q3791S76)
Propylene Glycol (UNII: 6DC9Q167V3)
Isoceteth-20 (UNII: O020065R7Z)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Disodium (UNII: 7FLD91C86K)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Benzoate (UNII: OJ245FE5EU)
Rice Oil (UNII: ACU8G2V809)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-353-01	1 in 1 CONTAINER	07/21/2011
1		12 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/21/2011

Labeler - RB Health (US) LLC (081049410)