Clearasil ® ULTRA ® Rapid Action Treatment Gel

Manufacturer
Reckitt Benckiser LLC
Effective date
2012-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:44:33

Label at a glance#

ProductClearasil Ultra Rapid Action Treatment
Active ingredientSalicylic Acid
Label structure11 sections

Dosage and administration

Cleanse the skin thoroughly before applying medication Cover the entire affected area with a thin layer one to three times daily Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 applications daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Storage and handling

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

Flammable keep away from extreme heat or open flame

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water
  • With 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 immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cleanse the skin thoroughly before applying medication
  • Cover the entire affected area with a thin layer one to three times daily
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 applications daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

STORAGE AND HANDLING SECTION

  • store in a cool dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol Denat., Polysorbate 20, Sorbitol, Hydroxyethylcellulose, Glycerin, Sodium Hydroxide, Fragrance, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Menthol, Disodium EDTA

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 LLC
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clearasil®

ULTRA®

Rapid Action
Treatment
Gel

Salicylic Acid 2%
Acne Medication

4
HOURS

Visibly
reduces
pimple size
and redness
in as little
as 4 hours

With Acceladerm®
Technology

1 FL. OZ. (28 g)

Principal Display Panel - 28 g Tube Carton
Principal Display Panel - 28 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ2
Salicylic AcidACTIVE MOIETYO414PZ4LPZ2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
Helichrysum Italicum FlowerINACTIVE INGREDIENTP62Y550X242
Lavandula Stoechas Flowering TopINACTIVE INGREDIENT70759G2U6A2
MentholINACTIVE INGREDIENTL7T10EIP3A2
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YH2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I2
SorbitolINACTIVE INGREDIENT506T60A25R2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-34163824-341-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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 8 · 422 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MentholMENTHOLL7T10EIP3AAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
SorbitolSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / RECTALNAExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR7.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR27 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPRAY, METERED / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ADROPS / OPHTHALMICNAExact identifier — unii candidate
24 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, DELAYED RELEASE / ORAL0.25 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETHRALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / ORAL400 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / IONTOPHORESISADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
SorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAOCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / TOPICAL3.7 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET, FILM COATED / ORAL8 mgExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 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
fc8abcd6-93a7-b846-e053-6294a90a4bd1c19ea241-9952-4251-bb4d-2db521bead942023-05-25WarningsExact identifier
spl set id: c19ea241-9952-4251-bb4d-2db521bead94

Reported adverse events (FAERS/openFDA)#

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