HANDI-KLEEN ANTIBACTERIAL FOAMING HAND- parachloirometaxlenol liquid

Handi-Kleen Antibacterial Foaming Hand by

Drug Labeling and Warnings

Handi-Kleen Antibacterial Foaming Hand by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Parachlorometaxylenol

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
• Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
• Stop use and ask a doctor if irritation or redness develop or if condition 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.

Keep away from children

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

Dosage & Administration

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

Inactive ingredient

Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water

Questions

Questions? Call 1-201-935-4300 for information

Handi-Kleen 1000 ml cartridge

999-SHK 1000                     Rev. 1.02

Handi-Kleen™

Antibacterial

Foaming Hand Wash

ADA       7  65574 16008  5

TSR No. 18070

1000ML

CARTRIDGE

MADE IN THE USA

STARCO®

CHEMICAL

A Division of Diamond Chemical Co., Inc.

Drug Facts

Active Ingredient                                         Purpose

Parachlorometaxylenol 0.3% w/w           Antiseptic

Uses

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

Warnings

• For external use only
• Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
• Stop use and ask a doctor if irritation or redness develop or if condition 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 minutes.
• Rinse under running water and dry thoroughly.

Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

Questions? Call 1-201-935-4300 for information

Handi-Kleen 6x1000 cartridge

999-SHK61000                    Rev. 1.02

Handi-Kleen™                                                   7  65574 16008 5

Antibacterial

Foaming Hand Wash

ADA       TSR No. 18070

MADE IN THE USA           6 x 1000ML CARTRIDGE

STARCO®

CHEMICAL

A Division of Diamond Chemical Co., Inc.

INGREDIENTS AND APPEARANCE

HANDI-KLEEN ANTIBACTERIAL FOAMING HAND 
parachloirometaxlenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-515
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
COCAMIDE (UNII: 3YXD33R71G)
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: 58575-515-01	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/15/2020
2	NDC: 58575-515-02	6000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/15/2020

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-515)