FDA.reportPublic FDA data

Clearasil Ultra

Manufacturer
Reckitt Benckiser LLC
Effective date
2015-08-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:27:41

Label at a glance#

ProductClearasil Ultra Acne plus Marks Wash and Mask
Active ingredientSalicylic Acid
Label structure11 sections

Dosage and administration

As a daily wash - wet face. Dispense product into hands, lather and massage gently onto face and neck, avoiding the eye area rinse thoroughly with warm water and gently pat dry. 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 or peeling occurs, reduce the application to o...

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%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

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

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

  • As a daily wash - wet face. Dispense product into hands, lather and massage gently onto face and neck, avoiding the eye area
  • rinse thoroughly with warm water and gently pat dry.
  • 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 or peeling occurs, reduce the application to once a day or every other day.
  • As a mask - use up to 3 times a week for a deeper treatment – wet face, apply on to damp skin. Leave on for 1 minute. Rinse off thoroughly with warm water. Gently pat dry.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, bentonite, kaolin, glycerin, titanium dioxide, sodium laureth sulfate, niacinamide, sodium lactate, xanthan gum, coco-glucoside, cocamidopropyl betaine, hexyldecanol, sodium hydroxide, fragrance, dipotassium glycyrrhizate, disodium EDTA, bisabolol, cetylhydroxyproline palmitamide, stearic acid, Brassica campestris sterols, FD&C blue no. 1, FD&C yellow no. 6

Questions?

OTC - QUESTIONS SECTION

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

You may also report side effects to this phone 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

Acne + Marks
Wash and Mask
Salicylic Acid 2% Acne Medication

REDUCES
MARKS

Helps to clear
pimples fast
and reduce the
appearance of
acne marks

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
63824-390-882023-09-07C16284748780-19d75b9d0-fc19-f424-e053-dadaa90a57ceClearasil ® Ultra Acne Plus Marks Wash and Mask
63824-390-882020-01-31C16284748780-19d75b9d0-fc19-f424-e053-dadaa90a57ceClearasil ® Ultra Acne Plus Marks Wash and Mask

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ1
Salicylic AcidACTIVE MOIETYO414PZ4LPZ1
BentoniteINACTIVE INGREDIENTA3N5ZCN45C1
Cetylhydroxyproline PalmitamideINACTIVE INGREDIENT74ONU0S62G1
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KX1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A81
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Glycyrrhizinate DipotassiumINACTIVE INGREDIENTCA2Y0FE3FX1
HexyldecanolINACTIVE INGREDIENT151Z7P13171
KaolinINACTIVE INGREDIENT24H4NWX5CO1
LevomenolINACTIVE INGREDIENT24WE03BX2T1
NiacinamideINACTIVE INGREDIENT25X51I8RD41
Rapeseed SterolINACTIVE INGREDIENTB46B6DD20U1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
Sodium LactateINACTIVE INGREDIENTTU7HW0W0QT1
Sodium Laureth SulfateINACTIVE INGREDIENTBPV390UAP01
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
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 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-39063824-390-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Water059QF0KO0RIACT
BentoniteA3N5ZCN45CIACT
Kaolin24H4NWX5COIACT
GlycerinPDC6A3C0OXIACT
Titanium Dioxide15FIX9V2JPIACT
Sodium Laureth-3 SulfateBPV390UAP0IACT
Niacinamide25X51I8RD4IACT
Sodium LactateTU7HW0W0QTIACT
Xanthan GumTTV12P4NEEIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
Hexyldecanol151Z7P1317IACT
Sodium Hydroxide55X04QC32IIACT
Glycyrrhizinate DipotassiumCA2Y0FE3FXIACT
Edetate Disodium7FLD91C86KIACT
Levomenol24WE03BX2TIACT
Cetylhydroxyproline Palmitamide74ONU0S62GIACT
Stearic Acid4ELV7Z65APIACT
Rapeseed SterolB46B6DD20UIACT
FD&C Blue No. 1H3R47K3TBDIACT
FD&C Yellow No. 6H77VEI93A8IACT

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 9 · 532 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IDISC / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / RECTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
NiacinamideNIACINAMIDE25X51I8RD4GEL / TOPICAL25 mgExact identifier — unii candidate
4 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium LactateSODIUM LACTATETU7HW0W0QTSOLUTION / INTRAPERITONEAL0.45 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / PERINEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / RECTALNAExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
KaolinKAOLIN24H4NWX5COTABLET, DELAYED RELEASE / ORAL18.5 mgExact identifier — unii candidate
13 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR27 mgExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETHRALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBARACHNOIDADJ PHExact identifier — unii candidate
174 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 HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium LactateSODIUM LACTATETU7HW0W0QTINJECTION / INTRAVENOUS54 mgExact identifier — unii candidate
7 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 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
fc8b3d1d-e16a-d377-e053-6394a90af48d04795bc0-86f2-411a-bb99-c7a9bb28e8af2023-05-25WarningsExact identifier
spl set id: 04795bc0-86f2-411a-bb99-c7a9bb28e8af

Reported adverse events (FAERS/openFDA)#

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