FDA.reportPublic FDA data

Clearasil ® Daily Clear ® Tinted Acne Treatment Cream

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 01:44:35

Label at a glance#

ProductClearasil Daily Clear Tinted Acne Treatment
Active ingredientBenzoyl Peroxide
Label structure11 sections

Dosage and administration

clean the skin thoroughly before applying this product 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 two or three times 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. if going outside, appl...

Storage and handling

keep tightly closed store at 20-25 °C (68-77 °F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

OTC - WHEN USING SECTION

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • 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.
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation becomes severe

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

  • clean the skin thoroughly before applying this product
  • 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 two or three times 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.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • keep tightly closed
  • store at 20-25 °C (68-77 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Aluminium Hydroxide, Bentonite, Glyceryl Stearate SE, PEG-12, Isopropyl Myristate, Simethicone, Methylparaben, Carbomer, Potassium Hydroxide, Propylparaben, Titanium Dioxide, Iron Oxides

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

Made in USA © RB 2011

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clearasil®

DAILY CLEAR®

Tinted Acne
Treatment Cream

Benzoyl Peroxide 10% Acne Medication

Maximum strength.
24 hour control
Clearer skin all day,
every day

TINTED

NET WT 1 OZ (28 g)

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-302-022023-08-31C16284748780-19d75b9d0-eaf1-f424-e053-dadaa90a57ceClearasil ® Daily Clear ® Tinted Acne Treatment Cream
63824-302-022020-01-31C16284748780-19d75b9d0-eaf1-f424-e053-dadaa90a57ceClearasil ® Daily Clear ® Tinted Acne Treatment Cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GM2
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GM2
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN02
BentoniteINACTIVE INGREDIENTA3N5ZCN45C2
Glyceryl Stearate SEINACTIVE INGREDIENTFCZ5MH785I2
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJS2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T2
Polyethylene Glycol 600INACTIVE INGREDIENTNL4J9F21N92
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4T2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V32
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-30263824-302-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
Water059QF0KO0RIACT
Propylene Glycol6DC9Q167V3IACT
Aluminum Hydroxide5QB0T2IUN0IACT
BentoniteA3N5ZCN45CIACT
Glyceryl Stearate SEFCZ5MH785IIACT
Polyethylene Glycol 600NL4J9F21N9IACT
Isopropyl Myristate0RE8K4LNJSIACT
MethylparabenA2I8C7HI9TIACT
Potassium HydroxideWZH3C48M4TIACT
PropylparabenZ8IX2SC1OHIACT
Titanium Dioxide15FIX9V2JPIACT

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 6 · 325 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii candidate
18 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION, CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii candidate
68 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, LIQUID FILLED / ORAL154 mgExact identifier — unii candidate
13 equally ranked IID candidates
Polyethylene Glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9CAPSULE, LIQUID FILLED / ORAL1584 mgExact identifier — unii candidate
9 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TRANSDERMAL113 mgExact identifier — unii candidate
18 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSOIL / TOPICAL213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
68 equally ranked IID candidates
Aluminum HydroxideALUMINUM HYDROXIDE5QB0T2IUN0OINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TGEL / TOPICAL3 mgExact identifier — unii candidate
13 equally ranked IID candidates
BentoniteBENTONITEA3N5ZCN45CTABLET / ORAL355 mgExact identifier — unii candidate
11 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
13 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSLOTION / TOPICAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSFILM / TRANSDERMAL58.08 mgExact identifier — unii candidate
18 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPOWDER / ORALNAExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
BentoniteBENTONITEA3N5ZCN45CCREAM / TOPICAL4.1 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
13 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCONCENTRATE / ORAL12 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
BentoniteBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSOINTMENT / TOPICAL35 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSOIL / AURICULAR (OTIC)36 mgExact identifier — unii candidate
18 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 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
fbe99827-0d7f-485d-e053-6294a90a5ce2da2f85ed-aa43-4852-be1f-3c43e9aab76a2023-05-17WarningsExact identifier
spl set id: da2f85ed-aa43-4852-be1f-3c43e9aab76a

Reported adverse events (FAERS/openFDA)#

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