INOFOAM ANTIBACTERIAL FOAMING HAND WASH- chloroxylenol liquid

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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Chloroxylenol 0.3% w/w

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

SPL UNCLASSIFIED SECTION

Inopak, LTD.

Ringwood, NJ 07456

1-800-767-7725 www.inopak.com

PRINCIPAL DISPLAY PANEL

INOFOAM

Antibacterial Foaming Hand Wash

With 0.3% Chloroxylenol

33.8 fl. oz. (1000 mL)

INGREDIENTS AND APPEARANCE

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)