PREMIUM FOAM ANTIBACTERIAL- 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 Premium Foam Antibacterial Handwash

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Uses

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, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Xylenesulfonate, Cocamide MEA, Glycerin, Isopropyl Alcohol, Lactic Acid, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Ammonium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 6 (CI 15985)

Product Label

PREMIUM FOAM ANTIBACTERIAL 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.003 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LACTIC ACID (UNII: 33X04XA5AT)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
JOJOBA OIL (UNII: 724GKU717M)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CORN OIL (UNII: 8470G57WFM)  
AMMONIUM SULFATE (UNII: SU46BAM238)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21749-085-23222 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2012
2NDC:21749-085-80800 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2012
3NDC:21749-085-891200 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2012
4NDC:21749-085-461360 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/11/2012
Labeler - GOJO Industries, Inc. (004162038)
Establishment
NameAddressID/FEIBusiness Operations
GOJO Industries, Inc.036424534MANUFACTURE(21749-085)
Establishment
NameAddressID/FEIBusiness Operations
GOJO Industries, Inc.088312414label(21749-085) , pack(21749-085)

Revised: 12/2019
Document Id: b756754c-0f2c-4740-8d82-e255057de0b8
Set id: 9863ec0b-4005-4bf2-a114-952331508d82
Version: 4
Effective Time: 20191223
 
GOJO Industries, Inc.