PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX- chloroxylenol liquid

PROVON Antimicrobial Ltn Sp with 0.3% PCMX by

Drug Labeling and Warnings

PROVON Antimicrobial Ltn Sp with 0.3% 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 0.3%

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), Coconut Acid, Oleic Acid, Sodium Sulfate, Ethanolamine, Cocamide MEA, Coco-Betaine, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Fragrance (Parfum)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-750
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chloroxylenol (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	Chloroxylenol	0.003 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Coconut Acid (UNII: 40U37V505D)
Oleic Acid (UNII: 2UMI9U37CP)
Sodium Sulfate (UNII: 0YPR65R21J)
MONOETHANOLAMINE (UNII: 5KV86114PT)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Coco-Betaine (UNII: 03DH2IZ3FY)
Propylene Glycol (UNII: 6DC9Q167V3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN OIL (UNII: 8470G57WFM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-750-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013
2	NDC: 21749-750-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013
3	NDC: 21749-750-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013
4	NDC: 21749-750-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013
5	NDC: 21749-750-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013
6	NDC: 21749-750-80	800 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013
7	NDC: 21749-750-10	1000 mL in 1 BAG; Type 0: Not a Combination Product	08/31/2013
8	NDC: 21749-750-20	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013
9	NDC: 21749-750-37	3784 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/31/2013

Labeler - GOJO Industries, Inc. (004162038)

Establishment
Name	Address	ID/FEI	Business Operations
GOJO Industries, Inc.		036424534	manufacture(21749-750)

Establishment
Name	Address	ID/FEI	Business Operations
GOJO Industries, Inc.		088312414	label(21749-750) , pack(21749-750)