MICRELL ANTIBACTERIAL FOAM HANDWASH - 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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MICRELL Antibacterial Foam Handwash

Active ingredient

Chloroxylenol 0.5%

Purpose

Antimicrobial

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

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, Green 3 (CI 42053), Red 33 (CI 17200)

Product Label

MICRELL ANTIBACTERIAL FOAM HANDWASH  
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.005 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21749-095-22200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2006
2NDC:21749-095-53535 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/23/2006
3NDC:21749-095-97700 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2006
4NDC:21749-095-891200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2006
5NDC:21749-095-901250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/23/2006
Labeler - GOJO Industries, Inc. (004162038)
Establishment
NameAddressID/FEIBusiness Operations
GOJO Industries, Inc.036424534manufacture(21749-095)
Establishment
NameAddressID/FEIBusiness Operations
GOJO Industries, Inc.088312414label(21749-095) , pack(21749-095)

Revised: 10/2017
Document Id: 53f64ed6-43d0-4d84-a11d-332f2d5fe989
Set id: 6413fd5c-f403-4e6c-95e5-a8774f305ede
Version: 2
Effective Time: 20171016
 
GOJO Industries, Inc.