GOJO PCMX E-2 SANITIZING LTN SP- chloroxylenol 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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GOJO® PCMX E-2 Sanitizing Lotion Soap

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Uses

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, Tetrasodium EDTA

Product Label

GOJO PCMX E-2 SANITIZING LTN SP
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-457
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)
EDETATE SODIUM (UNII: MP1J8420LU)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-457-80	800 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/25/2019
2	NDC:21749-457-20	2000 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/25/2019
3	NDC:21749-457-50	5000 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/25/2019
4	NDC:21749-457-37	3780 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/25/2019
5	NDC:21749-457-55	208000 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/25/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/25/2019

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	MANUFACTURE(21749-457)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	label(21749-457) , pack(21749-457)