PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM- 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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PURELL Healthcare HEALTHY SOAP 0.5% PCMX Antimicrobial Foam

Active ingredient

Chloroxylenol 0.5%

Purpose

Antimicrobial

Use

Handwash to help reduce bacteria on the skin
Recommended for repeated use

Warnings

For external use only

Wwhen 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, Ethanolamine, Dipropylene Glycol, Lactic Acid, Poloxamer 124, Isopropyl Alcohol, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Methylparaben, Propylparaben

Product Label

PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-522
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.005 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
LAURIC ACID (UNII: 1160N9NU9U)
MONOETHANOLAMINE (UNII: 5KV86114PT)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LACTIC ACID (UNII: 33X04XA5AT)
POLOXAMER 124 (UNII: 1S66E28KXA)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM SULFITE (UNII: VTK01UQK3G)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-522-53	535 mL in 1 PACKAGE; Type 0: Not a Combination Product	07/14/2017
2	NDC:21749-522-89	1200 mL in 1 PACKAGE; Type 0: Not a Combination Product	07/14/2017
3	NDC:21749-522-90	1250 mL in 1 PACKAGE; Type 0: Not a Combination Product	07/14/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/14/2017

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-522)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	label(21749-522) , pack(21749-522)