INOFOAM ANTIBACTERIAL FOAMING HAND- parachlorometaxylenol liquid

INOFOAM Antibacterial Foaming Hand by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug FactsActive Ingredient

Parachlorometaxylenol 0.3% w/w

Purpose

Antiseptic

Uses

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

Warnings

• For external use only.
• Keep out of eyes, ears or moutn. In case of eye contact, fluch eyes with water.
• Stop use and ask a doctor if irritation and redness develop or if condition persists for more that 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

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

Questions ?

Call 1-800-767-7725 or visit our wedsite www.inopak.com

INOFOAM Antibacterial Foaming Hand Wash 1000 ml

INOFOAM           5063-FL1000

Antibacterial Foaming Hand Wash            With 0.3% PCMX

1000 ml

MADE IN THE USA

INOPAK

Inopak, LTD.       Ringwood, NJ 07456

1-800-762-7725 www.inopak.com

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, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

Questions? Call 1-877-703-3044 or visit our website www.encoreindustrial.com

Inofoam 18 oz

INOFOAM           5063-432-02                        Rev. 1.02

Antibacterial Foaming Hand Wash            With 0.3% PCMX

18 fl oz.

(532 ml)

MADE IN THE USA

INOPAK

Inopak, LTD.       Ringwood, NJ 07456

1-800-762-7725 www.inopak.com

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 1-877-703-3044 or visit our website www.encoreindustrial.com

5063-432                              Rev. 1.02

Inofoam case

Antibacterial                                      INOFOAM

Foaming Hand Wash                       MADE IN THE USA

O   6/1000 ml Pouches                 O   6/1000 ml Cartridges

      55063-FL1000                                    5063-OS1000

                                                                                                                5063-CS  Rev. 1.0

  040232 65009 3                                 040232 65074 1                              Inopak, LTD.      

                                                                                                                Ringwood, NJ 07456

O   12/18 oz Bottles                       O   4/1 gal Bottles                                  1-800-762-7725

      5063-432-02                                5063-420-03                                     www.inopak.com

  040232 65061 1                                040232 65062 8                               INOPAK

INGREDIENTS AND APPEARANCE

INOFOAM ANTIBACTERIAL FOAMING HAND 
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-506
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.003 mg  in 1 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. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-506-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2017
2	NDC: 58575-506-18	540 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2017
3	NDC: 58575-506-42	3785 mL in 1 JUG; Type 0: Not a Combination Product	08/01/2017
4	NDC: 58575-506-43	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	08/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2017

Labeler - Inopak, Ltd (194718243)

Registrant - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-506)