FDA.reportPublic FDA data

Clearasil

Manufacturer
Reckitt Benckiser LLC
Effective date
2014-11-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:34:08

Label at a glance#

ProductClearasil Ultra 5 in 1 Exfoliating Wash
Active ingredientSalicylic Acid
Label structure11 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#

SPL UNCLASSIFIED SECTION

Drug Facts

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, 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?

OTC - QUESTIONS SECTION

1-866-252-5327.

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
63824-418-672023-09-07C16284748780-19d75b9d0-3a7e-f424-e053-dadaa90a57ceClearasil ® Ultra 5 in 1 Exfoliating Wash
63824-418-672020-01-31C16284748780-19d75b9d0-3a7e-f424-e053-dadaa90a57ceClearasil ® Ultra 5 in 1 Exfoliating Wash

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ1
Salicylic AcidACTIVE MOIETYO414PZ4LPZ1
alcoholINACTIVE INGREDIENT3K9958V90M1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171K1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
cetyl betaineINACTIVE INGREDIENTE945X08YA91
dimethyl palmitamineINACTIVE INGREDIENT5E4QI660PW1
distearyldimonium chlorideINACTIVE INGREDIENTOM9573ZX3X1
docosanolINACTIVE INGREDIENT9G1OE216XY1
edetate disodiumINACTIVE INGREDIENT7FLD91C86K1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBD1
ferric ferrocyanideINACTIVE INGREDIENTTLE294X33A1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
helichrysum italicum flowerINACTIVE INGREDIENTP62Y550X241
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR71
isopropyl alcoholINACTIVE INGREDIENTND2M4163021
lauryl alcoholINACTIVE INGREDIENT178A96NLP21
magnesium chlorideINACTIVE INGREDIENT02F3473H9O1
magnesium nitrateINACTIVE INGREDIENT77CBG3UN781
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPN1
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFA1
micaINACTIVE INGREDIENTV8A1AW08801
ppg-15 stearyl etherINACTIVE INGREDIENT1II18XLS1L1
sodium chlorideINACTIVE INGREDIENT451W47IQ8X1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141J1
sodium sulfateINACTIVE INGREDIENT0YPR65R21J1
steareth-2INACTIVE INGREDIENTV56DFE46J51
steareth-21INACTIVE INGREDIENT53J3F32P581
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1Y1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
waterINACTIVE INGREDIENT059QF0KO0R1
xanthan gumINACTIVE INGREDIENTTTV12P4NEE1

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
63824-41863824-418-67

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
high density polyethyleneUG00KM4WR7IACT
ppg-15 stearyl ether1II18XLS1LIACT
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 disodium7FLD91C86KIACT
butylated hydroxytoluene1P9D0Z171KIACT
magnesium nitrate77CBG3UN78IACT
methylchloroisothiazolinoneDEL7T5QRPNIACT
magnesium chloride02F3473H9OIACT
methylisothiazolinone229D0E1QFAIACT
sodium sulfate0YPR65R21JIACT
ferric ferrocyanideTLE294X33AIACT
titanium dioxide15FIX9V2JPIACT
FD&C blue no. 1H3R47K3TBDIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 11 · 609 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
xanthan gumXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
sodium sulfateSODIUM SULFATE0YPR65R21JTABLET, DELAYED RELEASE / ORAL16.24 mgExact identifier — unii candidate
7 equally ranked IID candidates
sodium sulfateSODIUM SULFATE0YPR65R21JSOLUTION / OPHTHALMIC0.14 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE / ORAL10 mgExact identifier — unii candidate
18 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / INTRAMUSCULAR9 mgExact identifier — unii candidate
134 equally ranked IID candidates
steareth-21STEARETH-2153J3F32P58LOTION / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRATHECAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / TOPICAL0.32 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, EFFERVESCENT / ORAL1.5 mgExact identifier — unii candidate
42 equally ranked IID candidates
alcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii candidate
134 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / IONTOPHORESIS0.6 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
12 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JOINTMENT / TOPICAL14 mgExact identifier — unii candidate
42 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDMOUTHWASH / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOAP / TOPICAL1.26 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, DELAYED RELEASE / ORAL199 mgExact identifier — unii candidate
42 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAOCULAR320 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / OPHTHALMIC10 mgExact identifier — unii candidate
134 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates

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
fc8b5e14-9e95-492f-e053-6394a90acdaf04ce156e-d2ff-41ab-9848-eaacaa56d8ba2023-05-25WarningsExact identifier
spl set id: 04ce156e-d2ff-41ab-9848-eaacaa56d8ba

Reported adverse events (FAERS/openFDA)#

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