PROVON ANTIBACTERIAL PLUM FOAM HANDWASH- triclosan liquid
GOJO Industries, Inc.

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.

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PROVON Antibacterial Plum Foam Handwash

Active ingredient

Triclosan 0.3%

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 a small amount of product and work into a lather

• Rinse well and dry hands completely

Inactive Ingredients

Water (Aqua), Alcohol, Lauric Acid, Propylene Glycol, Ethanolamine, Disodium Cocoamphodiacetate, Isopropyl Alcohol, Polyquaternium-10, Prunus Domestica Fruit Extract, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200)

Product Label

PROVON ANTIBACTERIAL PLUM FOAM HANDWASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-542
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Triclosan (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	Triclosan	0.003 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Lauric Acid (UNII: 1160N9NU9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MONOETHANOLAMINE (UNII: 5KV86114PT)
Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)
Isopropyl Alcohol (UNII: ND2M416302)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
PLUM (UNII: 67M3EQ6BE1)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Sodium Sulfite (UNII: VTK01UQK3G)
EDETATE SODIUM (UNII: MP1J8420LU)
Sodium Sulfate (UNII: 0YPR65R21J)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-542-97	700 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2011
2	NDC:21749-542-89	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2011
3	NDC:21749-542-90	1250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/01/2011	12/01/2021

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-542)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	label(21749-542) , pack(21749-542)

Revised: 11/2018

Document Id: e41b4e5a-3dd7-4363-b708-2f4cca8912bd

Set id: e4140fc0-8d72-4cb7-bdfd-a7f10c7248bd

Version: 3

Effective Time: 20181119

GOJO Industries, Inc.