Clearasil ULTRA® Overnight Scrub

Drug Labeling and Warnings

Drug Details [pdf]

CLEARASIL ULTRA  OVERNIGHT SCRUB- salicylic acid solution 
RB Health US (LLC)

Disclaimer: 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.

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Clearasil
ULTRA®
Overnight Scrub

Drug Facts

Active Ingredient

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.
• 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.

Stop use and ask 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

• Wet face
• Dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area.
• Rinse thoroughly with warm water and pat dry.
• Use as part of your night time regime.

Other information

• keep tightly closed
• store in a cool dry place.

Inactive ingredients

Water, PPG-15 Stearyl Ether, Glycerin, Stearyl Alcohol, Cetyl Betaine, Polyethylene, Distearyldimonium Chloride, Sodium Lauryl Sulfate, Sodium Hydroxide, Cetyl Alcohol, Alcohol, Steareth-21, Sodium Chloride, Behenyl Alcohol, PPG-30, Steareth-2, Fragrance, Disodium EDTA, Isopropanol, BHT, Zinc Stearate, Red 30, Blue 1 Lake, Red 33, Blue 1.

Questions? Comments?

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 France © RB 2011

www.clearasil.com

PRINCIPAL DISPLAY PANEL - 150 mL Tube Label

Clearasil®

ULTRA®

Overnight
Scrub

Salicylic Acid 2% Acne Medication

For visibly
clearer skin
and reduced
pimple redness
overnight

5 FL. OZ. (150 mL)

CLEARASIL ULTRA   OVERNIGHT SCRUB
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-352
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)
Glycerin (UNII: PDC6A3C0OX)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Cetyl Betaine (UNII: E945X08YA9)
Distearyldimonium Chloride (UNII: OM9573ZX3X)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Sodium Hydroxide (UNII: 55X04QC32I)
Cetyl Alcohol (UNII: 936JST6JCN)
Alcohol (UNII: 3K9958V90M)
Steareth-21 (UNII: 53J3F32P58)
Sodium Chloride (UNII: 451W47IQ8X)
Docosanol (UNII: 9G1OE216XY)
Steareth-2 (UNII: V56DFE46J5)
Edetate Disodium (UNII: 7FLD91C86K)
Isopropyl Alcohol (UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Zinc Stearate (UNII: H92E6QA4FV)
D&C Red No. 30 (UNII: 2S42T2808B)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
Aluminum Oxide (UNII: LMI26O6933)
D&C Red No. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-352-01	150 mL in 1 TUBE; Type 0: Not a Combination Product	04/05/2011	09/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/05/2011	09/02/2019

Labeler - RB Health US (LLC) (081049410)

Revised: 9/2019

Document Id: 5c1cff5e-2665-4d64-b819-521cbffa7f0e

34390-5

Set id: 4089c105-beb5-4711-a29f-854ff0fa4a17

Version: 4

Effective Time: 20190918