CLEARASIL ULTRA RAPID ACTION SCRUB- salicylic acid cream

Clearasil by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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, PPG-15 stearyl ether, hydrated silica, glycerin, stearyl alcohol, cetyl betaine, distearyldimonium chloride, sodium lauryl sulfate, cetyl alcohol, alcohol denat, steareth-21, sodium chloride, behenyl alcohol, synthetic wax, steareth-2, fragrance, Lavandula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract, xanthan gum, dimethyl palmitamine, lauryl alcohol, mica, isopropyl alcohol, disodium EDTA, BHT, magnesium nitrate, methylchloroisothiazolinone, magnesium chloride, methylisothiazolinone, sodium sulfate, 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

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

Made in USA

PRINCIPAL DISPLAY PANEL - 150 mL Tube Label

Clearasil®

ULTRA

Rapid Action
Face Scrub
Salicylic Acid 2% Acne Medication

MAXIMUM STRENGTH

12
HRS

Visibly
clearer skin
in as fast as
12 hours

5 FL OZ (150 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL   ULTRA RAPID ACTION SCRUB
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-428
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-15 stearyl ether (UNII: 1II18XLS1L)
hydrated silica (UNII: Y6O7T4G8P9)
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)
helichrysum italicum flower (UNII: P62Y550X24)
xanthan gum (UNII: TTV12P4NEE)
dimethyl palmitamine (UNII: 5E4QI660PW)
lauryl alcohol (UNII: 178A96NLP2)
mica (UNII: V8A1AW0880)
isopropyl alcohol (UNII: ND2M416302)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
magnesium nitrate (UNII: 77CBG3UN78)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
magnesium chloride (UNII: 02F3473H9O)
methylisothiazolinone (UNII: 229D0E1QFA)
sodium sulfate (UNII: 0YPR65R21J)
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: 63824-428-01	150 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	09/01/2016

Labeler - Reckitt Benckiser LLC (094405024)