INOFOAM ANTIBACTERIAL FOAMING HAND WASH- chloroxylenol liquid 
Inopak, Ltd

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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INOFOAM Antibacterial Foaming Hand Wash

Drug Facts

Active ingredient

Chloroxylenol 0.3% w/w

Purpose

Antiseptic

Uses

  • Handwash to help reduce bacteria on the skin that potentially can cause disease.
  • Recommended for repeated use.

Warnings

For external use only

When using this product keep out of eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation and redness develop or if condtion persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
  • Wash both hands thoroughly for 15 seconds.
  • Rince under running water and dry thoroughly.

Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, Phenoxyethanol, Isopropyl Alcohol, Fragrance, Citric Acid, FD&C Red No. 4

Inopak, LTD.

Ringwood, NJ 07456

1-800-767-7725 • www.inopak.com

INOFOAM

Antibacterial Foaming Hand Wash

With 0.3% Chloroxylenol

33.8 fl. oz. (1000 mL)

Inofoam Foam HW 1000mL 58575-516

INOFOAM ANTIBACTERIAL  FOAMING HAND WASH
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-516
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58575-516-011000 mL in 1 POUCH; Type 0: Not a Combination Product02/15/202101/20/2024
2NDC:58575-516-18540 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/15/202105/19/2024
3NDC:58575-516-423785 mL in 1 JUG; Type 0: Not a Combination Product02/15/202101/20/2024
4NDC:58575-516-111000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product02/15/202105/19/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/15/202105/19/2024
Labeler - Inopak, Ltd (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd194718243manufacture(58575-516)

Revised: 2/2023
Document Id: f5177ac5-c749-3703-e053-2995a90a0119
Set id: bb66f952-235a-0aef-e053-2a95a90a4723
Version: 2
Effective Time: 20230219
 
Inopak, Ltd