FDA.reportPublic FDA data

Clear Proof Acne Treatment

Product NDC
51531-9071
11-digit product format
515319071
Labeler code
51531
Product ID
51531-9071_5d1ae085-93cf-6664-e063-6394a90a60c6
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Mary Kay Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-15
Marketing end
2028-07-14
Substance
BENZOYL PEROXIDE
Active strength
5 g/100g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Clear Proof Acne Treatment
Brand name suffix
Acne Medication

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE5 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-9071-0Clear Proof Acne TreatmentAcne Medication3 g in 1 TUBEGEL37
51531-9071-1Clear Proof Acne TreatmentAcne Medication28 g in 1 TUBEGEL287
51531-9071-1Clear Proof Acne TreatmentAcne Medication1 in 1 CARTONGEL17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GMCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GMCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
1,3-BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
CucumberINACTIVE INGREDIENTYY7C30VXJTCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
DENATONIUM BENZOATEINACTIVE INGREDIENT4YK5Z54AT2CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Docusate SodiumINACTIVE INGREDIENTF05Q2T2JA0CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Echinacea PurpureaINACTIVE INGREDIENTQI7G114Y98CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Horse ChestnutINACTIVE INGREDIENT3C18L6RJAZCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Poloxamer 182INACTIVE INGREDIENTJX0HIX6OAGCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ICLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
TERT-BUTYL ALCOHOLINACTIVE INGREDIENTMD83SFE959CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-9071CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]7Current NDC, Legacy NDC, 3 package rows20241222_e01859b1-057e-4b01-8b37-2df378aae212.zip

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 49 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLEAR IMPROVEMENT BLACKHEAD CLEARING MASK TO SCRUBSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.10a54180-5ad9-d4af-e063-6394a90a26f92024-02-05WarningsExact identifier
application number: M006
OXY Rapid Spot Treatment Maximum ActionBENZOYL PEROXIDEThe Mentholatum Company226dad56-e415-41ec-937a-4282c73f0d342024-01-23WarningsExact identifier
application number: M006
Caring mill Acne TreatmentBENZOYL PEROXIDEFSA Store Inc.0ec20ba4-9251-fbb3-e063-6394a90a2ad62024-01-12WarningsExact identifier
application number: M006
CeraVe Acne Foaming CreamWashBENZOYL PEROXIDEL'Oreal USA Products Inc06950d35-daa8-4ea3-bd33-6e9c162e2a632024-01-09WarningsExact identifier
application number: M006
Peace Out Acne Day and Night DuoSALICYLIC ACIDPeace Out LLC.ecacd6ab-a5ce-a516-e053-2995a90a44142024-01-03WarningsExact identifier
application number: M006
Peace Out Acne Day and Night DuoSALICYLIC ACIDPeace Out LLC.ecbf7dec-fc5a-156a-e053-2995a90af0852024-01-03WarningsExact identifier
application number: M006
Garnier Clean Blackhead Eliminating ScrubSALICYLIC ACIDL'Oreal USA Products Inccb389547-ad1d-4c51-8c2e-bf3fc58972822024-01-02WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar ClarifyingSALICYLIC ACIDL'Oreal USA Products Incdebff755-c83d-42c0-80fc-be73952eceb42024-01-01WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Daily Gentle CleanserSALICYLIC ACIDL'Oreal USA Products Incb34515cb-0495-4f70-be40-508df29902862024-01-01WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists Acne Control CleanserSALICYLIC ACIDL'Oreal USA Products Inc00203b2a-74dd-45a5-977a-3ef4eb3145772023-12-31WarningsExact identifier
application number: M006
La Roche Posay Laboratorie Dermatologique Effaclar Medicated CleanserSALICYLIC ACIDL'Oreal USA Products Inc8a6e2634-2497-403a-af03-113bf35fe36a2023-12-31WarningsExact identifier
application number: M006
CeraVe Acne Foaming CleanserBENZOYL PEROXIDEL'Oreal USA Products Incd9c11b75-14ee-46e3-9b1d-c349a102e2fd2023-12-31WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne TreatmentBENZOYL PEROXIDEL'OREAL USA, INC.8ed6ee51-816e-4c83-a437-4ceaa339b1302023-12-31WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists Acne Control Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2532352e-eabc-4565-9437-b8801db6937a2023-12-31WarningsExact identifier
application number: M006
Kiehls Since 1851 Blue Herbal Acne Cleanser Treatment with Frankincense and Ginger RootSALICYLIC ACIDL'Oreal USA Products Incd8ad899b-a4d9-4720-aa37-b35d95ff899c2023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot TreatmentSULFURL'Oreal USA Products Inc217c697e-0260-46d5-a202-ce7345eadd942023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and PreventingSALICYLIC ACIDL'Oreal USA Products Inc14429a1d-7db9-49a7-85d6-22374d03ecaa2023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Truly Targeted Acne Clearing SolutionSALICYLIC ACIDL'Oreal USA Products Inc55f614ee-f0fb-425d-aa5e-f90cad51c2852023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Blue Herbal Acne Cleanser TreatmentSALICYLIC ACIDL'Oreal USA Products Inc09e7f362-6187-4e49-b703-8249c70e51242023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Breakout Control Acne Treatment FacialSALICYLIC ACIDL'Oreal USA Products Inc3346f5f8-5793-47f6-8e71-250d3cc05c0d2023-12-30WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSNe01859b1-057e-4b01-8b37-2df378aae2127
1489132clearproof Acne Treatment 5 % Topical GelPSNe01859b1-057e-4b01-8b37-2df378aae2127
1489132benzoyl peroxide 0.05 MG/MG Topical Gel [Clear Proof Acne Treatment]SBDe01859b1-057e-4b01-8b37-2df378aae2127
308694benzoyl peroxide 0.05 MG/MG Topical GelSCDe01859b1-057e-4b01-8b37-2df378aae2127
308694benzoyl peroxide 5 % Topical GelSYe01859b1-057e-4b01-8b37-2df378aae2127
1489132Clear Proof Acne Treatment 0.05 MG/MG Topical GelSYe01859b1-057e-4b01-8b37-2df378aae2127
1489132Clear Proof Acne Treatment 5 % Topical GelSYe01859b1-057e-4b01-8b37-2df378aae2127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51531-9071-0515319071003 g in 1 TUBE (51531-9071-0) 3 g2016-08-162028-07-14NoNoCurrent
51531-9071-1515319071011 TUBE in 1 CARTON (51531-9071-1) / 28 g in 1 TUBE1 tube2016-08-162028-07-14NoNoCurrent