Label: PROVON FOAMING ANTIMICROBIAL HANDWASH WITH PCMX- chloroxylenol liquid
-
NDC Code(s):
21749-541-20,
21749-541-53,
21749-541-89,
21749-541-90, view more21749-541-97
- Packager: GOJO Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 16, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROVON FOAMING ANTIMICROBIAL HANDWASH WITH PCMX
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-541 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.005 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) LAURIC ACID (UNII: 1160N9NU9U) MONOETHANOLAMINE (UNII: 5KV86114PT) DIPROPYLENE GLYCOL (UNII: E107L85C40) LACTIC ACID (UNII: 33X04XA5AT) POLOXAMER 124 (UNII: 1S66E28KXA) ISOPROPYL ALCOHOL (UNII: ND2M416302) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM SULFITE (UNII: VTK01UQK3G) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM SULFATE (UNII: 0YPR65R21J) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21749-541-53 535 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2013 2 NDC:21749-541-97 700 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2013 3 NDC:21749-541-89 1200 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2013 4 NDC:21749-541-90 1250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2013 5 NDC:21749-541-20 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2013 Labeler - GOJO Industries, Inc. (004162038) Establishment Name Address ID/FEI Business Operations GOJO Industries, Inc. 036424534 manufacture(21749-541) Establishment Name Address ID/FEI Business Operations GOJO Industries, Inc. 088312414 label(21749-541) , pack(21749-541)