FDA.reportPublic FDA data

PROVON Antimicrobial Ltn Sp with 0.3% PCMX

Product NDC
21749-750
11-digit product format
217490750
Labeler code
21749
Product ID
21749-750_4c38ea89-7cb8-a37a-e063-6394a90a5ebd
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
LIQUID
Route
TOPICAL
Labeler
GOJO Industries, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-31
Substance
CHLOROXYLENOL
Active strength
.003 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROVON Antimicrobial Ltn Sp with 0.3% PCMX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL.003 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0F32U78V2Q

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21749-750-04PROVON Antimicrobial Ltn Sp with 0.3% PCMX118 mL in 1 BOTTLELIQUID1185
21749-750-08PROVON Antimicrobial Ltn Sp with 0.3% PCMX236 mL in 1 BOTTLELIQUID2365
21749-750-10PROVON Antimicrobial Ltn Sp with 0.3% PCMX1000 mL in 1 BAGLIQUID10005
21749-750-12PROVON Antimicrobial Ltn Sp with 0.3% PCMX355 mL in 1 BOTTLELIQUID3555
21749-750-16PROVON Antimicrobial Ltn Sp with 0.3% PCMX473 mL in 1 BOTTLELIQUID4735
21749-750-20PROVON Antimicrobial Ltn Sp with 0.3% PCMX2000 mL in 1 BOTTLELIQUID20005
21749-750-37PROVON Antimicrobial Ltn Sp with 0.3% PCMX3784 mL in 1 BOTTLELIQUID37845
21749-750-50PROVON Antimicrobial Ltn Sp with 0.3% PCMX500 mL in 1 BOTTLELIQUID5005
21749-750-80PROVON Antimicrobial Ltn Sp with 0.3% PCMX800 mL in 1 BOTTLELIQUID8005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2QPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
COCO-BETAINEINACTIVE INGREDIENT03DH2IZ3FYPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
COCONUT ACIDINACTIVE INGREDIENT40U37V505DPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
CORN OILINACTIVE INGREDIENT8470G57WFMPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21749-750PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]4Current NDC, Legacy NDC, 9 package rows20241210_d9dfd7fe-6a24-4815-a9c8-4c45b4bf65b3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21749-750-0421749075004118 mL in 1 BOTTLE (21749-750-04) 118 ml2013-08-310000-00-00NoNoCurrent
21749-750-0821749075008236 mL in 1 BOTTLE (21749-750-08) 236 ml2013-08-310000-00-00NoNoCurrent
21749-750-10217490750101000 mL in 1 BAG (21749-750-10) 1000 ml2013-08-312026-10-31NoNoCurrent
21749-750-1221749075012355 mL in 1 BOTTLE (21749-750-12) 355 ml2013-08-310000-00-00NoNoCurrent
21749-750-1621749075016473 mL in 1 BOTTLE (21749-750-16) 473 ml2013-08-310000-00-00NoNoCurrent
21749-750-20217490750202000 mL in 1 BOTTLE (21749-750-20) 2000 ml2013-08-312026-08-31NoNoCurrent
21749-750-37217490750373784 mL in 1 BOTTLE (21749-750-37) 3784 ml2013-08-310000-00-00NoNoCurrent
21749-750-5021749075050500 mL in 1 BOTTLE (21749-750-50) 500 ml2013-08-310000-00-00NoNoCurrent
21749-750-8021749075080800 mL in 1 BOTTLE (21749-750-80) 800 ml2013-08-310000-00-00NoNoCurrent