PROVON ANTIBACTERIAL PERINEAL WASH- 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 Perineal Wash

Active ingredient

Triclosan 0.15 %

Purpose

Antimicrobial

Use

Cleans and helps reduce bacteria on the skin that could cause disease and odor

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

• Remove excess fecal matter.

• Apply product to warm damp wash cloth(s).

• Gently clean entire perineal area, always wiping from front to back.

• Repeat with additional washcloths as needed.

Inactive Ingredients

Water (Aqua), Sodium Lactate, Coco-Betaine, Disodium EDTA, Lactic Acid, Lauramine Oxide, PEG-4, Fragrance (Parfum), Iodopropynyl Butylcarbamate

Product Label

PROVON ANTIBACTERIAL PERINEAL WASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-430
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.0015 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Sodium Lactate (UNII: TU7HW0W0QT)
Coco-Betaine (UNII: 03DH2IZ3FY)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Lactic Acid (UNII: 33X04XA5AT)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21749-430-08	236 mL in 1 PACKAGE; Type 0: Not a Combination Product	08/01/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/01/2010	12/01/2021

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-430)

Revised: 11/2018

Document Id: ba3dd10a-5cc6-4254-ab79-897b0dbe22bb

Set id: 3862b0f6-9907-42f3-8f39-09ab3ab7e295

Version: 2

Effective Time: 20181119

GOJO Industries, Inc.