Clearasil® Ultra Rapid Action Face Scrub

Drug Labeling and Warnings

Drug Details [pdf]

CLEARASIL ULTRA RAPID ACTION  FACE SCRUB- salicylic acid lotion 
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 Rapid Action
Face 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.
• 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

• wet face
• dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area
• cover the entire affected area with a thin layer and rinse thoroughly with warm water one to three times daily
• 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 occurs, reduce application to once a day or every other day

Other information

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

Inactive ingredients

water, polyethylene, PPG-15 stearyl ether, glycerin, stearyl alcohol, cetyl betaine, distearyldimonium chloride, sodium lauryl sulfate, cetyl alcohol, alcohol, steareth-21, sodium chloride, behenyl alcohol, steareth-2, synthetic wax, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, xanthan gum, lauryl alcohol, mica, disodium EDTA, BHT, ferric ferrocyanide, titanium dioxide, FD&C blue no. 1

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 France © 2012 RB

PRINCIPAL DISPLAY PANEL - 150 mL Tube Label

+33% FREE
vs. 5 FL OZ size

Clearasil®

ULTRA

Rapid Action
Face Scrub

Salicylic Acid 2% Acne Medication

12
HOURS
Visibly
clearer
skin in as
little as
12 hours

6.78 FL OZ (200 mL)

CLEARASIL ULTRA RAPID ACTION   FACE SCRUB
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-385
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)
High Density Polyethylene (UNII: UG00KM4WR7)
Glycerin (UNII: PDC6A3C0OX)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Cetyl Betaine (UNII: E945X08YA9)
Distearyldimonium Chloride (UNII: OM9573ZX3X)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Cetyl Alcohol (UNII: 936JST6JCN)
Alcohol (UNII: 3K9958V90M)
Steareth-21 (UNII: 53J3F32P58)
Sodium Chloride (UNII: 451W47IQ8X)
Docosanol (UNII: 9G1OE216XY)
Steareth-2 (UNII: V56DFE46J5)
Lavandula Stoechas Flowering Top (UNII: 70759G2U6A)
Helichrysum Italicum Flower Oil (UNII: O97ZV7726K)
Xanthan Gum (UNII: TTV12P4NEE)
Lauryl Alcohol (UNII: 178A96NLP2)
Mica (UNII: V8A1AW0880)
Edetate Disodium (UNII: 7FLD91C86K)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Ferric Ferrocyanide (UNII: TLE294X33A)
Titanium Dioxide (UNII: 15FIX9V2JP)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-385-65	150 mL in 1 TUBE; Type 0: Not a Combination Product	06/29/2012	09/02/2019
2	NDC: 63824-385-67	200 mL in 1 TUBE; Type 0: Not a Combination Product	06/29/2012	09/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/29/2012	09/02/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 9/2019

Document Id: 484944c1-3057-4b19-a374-835efdf4bd7e

34390-5

Set id: 34c5b164-4e63-4864-80f4-0b514d36a088

Version: 4

Effective Time: 20190924