PROVON FOAMING ANTIMICROBIAL HANDWASH WITH PCMX- chloroxylenol liquid

PROVON Foaming Antimicrobial Handwash with PCMX by

Drug Labeling and Warnings

PROVON Foaming Antimicrobial Handwash with PCMX by is a Otc medication manufactured, distributed, or labeled by GOJO Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chloroxylenol 0.5%

Purpose

Antimicrobial

Use

• Handwash to help decrease bacteria on the skin 
• Recommended for repeated use

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wet hands. 
• Apply product and thoroughly cover hands with lather. 
• Rinse well and dry hands completely.

Inactive ingredients

Water (Aqua), Alcohol, Lauric Acid, Ethanolamine, Dipropylene Glycol, Lactic Acid, Poloxamer 124, Isopropyl Alcohol, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Methylparaben, Propylparaben, Green 3 (CI 42053), Red 33 (CI 17200)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVON FOAMING ANTIMICROBIAL HANDWASH WITH PCMX 
chloroxylenol liquid

Product 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)