CLEARASIL ULTRA 5 IN 1 EXFOLIATING WASH- salicylic acid solution

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]

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Drug Facts

Active ingredient

Salicylic acid 2.0%

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.
• using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. 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 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 and dispense product into hands, lather and massage gently onto face and neck, avoiding the 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, 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?

1-866-252-5327.

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Distributed by:
Reckitt Benckiser
Parsippany, NJ
07054-0224
Made in USA

PRINCIPAL DISPLAY PANEL - 200 mL Tube Label

Clearasil®

ULTRA

Salicylic Acid 2.0% Acne Medication

5
IN 1
EXFOLIATING
WASH
FIGHTS 5 ACNE
PROBLEMS

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

6.78 FL. OZ. (200 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL   ULTRA 5 IN 1 EXFOLIATING WASH
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-418
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)
ppg-15 stearyl ether (UNII: 1II18XLS1L)
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 (UNII: 7FLD91C86K)
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: 63824-418-67	200 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	01/01/2015

Labeler - Reckitt Benckiser LLC (094405024)