FDA.reportPublic FDA data

Clearasil

Manufacturer
Reckitt Benckiser LLC
Effective date
2016-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:22:53

Label at a glance#

ProductClearasil Ultra 5-In-1 Exfoliating Wash
Active ingredientSalicylic Acid
Label structure10 sections

Dosage and administration

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 occ...

Storage and handling

keep tightly closed store in a cool, dry place

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

call 1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 200 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

PRINCIPAL DISPLAY PANEL - 200 mL Tube Label
PRINCIPAL DISPLAY PANEL - 200 mL Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-425-012023-09-07C16284748780-19d75b9d0-cf8b-f424-e053-dadaa90a57ceClearasil ® Ultra 5-In-1 Exfoliating Wash
63824-425-012020-01-31C16284748780-19d75b9d0-cf8b-f424-e053-dadaa90a57ceClearasil ® Ultra 5-In-1 Exfoliating Wash

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-42563824-425-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
water059QF0KO0RIACT
PPG-15 stearyl ether1II18XLS1LIACT
hydrated silicaY6O7T4G8P9IACT
glycerinPDC6A3C0OXIACT
stearyl alcohol2KR89I4H1YIACT
cetyl betaineE945X08YA9IACT
distearyldimonium chlorideOM9573ZX3XIACT
sodium lauryl sulfate368GB5141JIACT
cetyl alcohol936JST6JCNIACT
alcohol3K9958V90MIACT
steareth-2153J3F32P58IACT
sodium chloride451W47IQ8XIACT
docosanol9G1OE216XYIACT
steareth-2V56DFE46J5IACT
helichrysum italicum flowerP62Y550X24IACT
xanthan gumTTV12P4NEEIACT
dimethyl palmitamine5E4QI660PWIACT
lauryl alcohol178A96NLP2IACT
micaV8A1AW0880IACT
isopropyl alcoholND2M416302IACT
edetate disodium anhydrous8NLQ36F6MMIACT
butylated hydroxytoluene1P9D0Z171KIACT
magnesium nitrate77CBG3UN78IACT
methylchloroisothiazolinoneDEL7T5QRPNIACT
magnesium chloride02F3473H9OIACT
methylisothiazolinone229D0E1QFAIACT
sodium sulfate0YPR65R21JIACT
ferric ferrocyanideTLE294X33AIACT
titanium dioxide15FIX9V2JPIACT
FD&C blue no. 1H3R47K3TBDIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fc8bc578-45f6-53c3-e053-6394a90aa7df67eba3f0-2b0d-411e-9958-0aa523d9e5422023-05-25WarningsExact identifier
spl set id: 67eba3f0-2b0d-411e-9958-0aa523d9e542

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.