DailyMed - PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX- chloroxylenol liquid

NDC Code(s): 21749-750-04, 21749-750-08, 21749-750-10, 21749-750-12, view more
21749-750-16, 21749-750-20, 21749-750-37, 21749-750-50, 21749-750-80
Packager: GOJO Industries, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated December 9, 2024

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Active ingredient
Chloroxylenol 0.3%

Chloroxylenol 0.3%
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Purpose
Antimicrobial

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

• Handwash to help decrease bacteria on the skin

• Recommended for repeated use
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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 ...

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.

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Directions
• Wet hands - • Apply a small amount of product and work into a lather - • Rinse well and dry hands completely

• Wet hands

• Apply a small amount of product and work into a lather

• Rinse well and dry hands completely
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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 ...

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)
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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

Product Information

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	12/09/2024
3	NDC:21749-750-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013	12/09/2024
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	12/09/2024
6	NDC:21749-750-80	800 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013	12/09/2024
7	NDC:21749-750-10	1000 mL in 1 BAG; Type 0: Not a Combination Product	08/31/2013	10/31/2026
8	NDC:21749-750-20	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013	08/31/2026
9	NDC:21749-750-37	3784 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2013	05/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	08/31/2013

Labeler - GOJO Industries, Inc. (004162038)

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

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

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Published Date (What is this?)	Version	Files
Dec 10, 2024	4 (current)	download
Sep 18, 2017	3	download
Jul 31, 2017	2	download
Jan 6, 2014	1	download

Label: PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX- chloroxylenol liquid

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	NDC
1	21749-750-04
2	21749-750-08
3	21749-750-10
4	21749-750-12
5	21749-750-16
6	21749-750-20
7	21749-750-37
8	21749-750-50
9	21749-750-80

Label: PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX- chloroxylenol liquid

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PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX- chloroxylenol liquid

Number of versions: 4

PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX- chloroxylenol liquid

PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX- chloroxylenol liquid

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PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX- chloroxylenol liquid

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.