INOFOAM Antibacterial Foaming Hand Wash

INOFOAM Antibacterial by

Drug Labeling and Warnings

INOFOAM Antibacterial by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ANTIBACTERIAL  FOAMING HAND WASH
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-516
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-516-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product	02/15/2021	01/20/2024
2	NDC: 58575-516-18	540 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/15/2021	05/19/2024
3	NDC: 58575-516-42	3785 mL in 1 JUG; Type 0: Not a Combination Product	02/15/2021	01/20/2024
4	NDC: 58575-516-11	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	02/15/2021	05/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/15/2021	05/19/2024

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-516)

Revised: 2/2023

Document Id: f5177ac5-c749-3703-e053-2995a90a0119

34390-5

Set id: bb66f952-235a-0aef-e053-2a95a90a4723

Version: 2

Effective Time: 20230219