ANTIBACTERIAL LIQUID HAND- parachlorometaxylenol liquid
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.

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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Antibacterial Liquid Hand Soap

ACTIVE INGREDIENT

Parachlorometaxylenol 0.3%

Purpose

Antibacterial

USES

For hand washing to decrease bacteria on the skin

Warnings For external Use only

When Using this Product- Avoid contact with the eyes.

In case of eye contact, fluch eyes with water.

Stop use and ask a doctor if irritation or redness develops

or if condition persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help

or contact Posion Control Center right away.

Directions

-Pump into hands, wet as needed.

-Lather skin Vigorously for at least 15 seconds.

-Wash skin, rinse thoroughly and dry.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Decyl Glocoside, Glycerine, Aloe Vera, Sodium Chloride, DMDM Hydation, Fragrance, FD&C Blue #1

Antibacterial Liquid Hand

image description

ANTIBACTERIAL LIQUID HAND
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50241-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
chloroxylenol (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	chloroxylenol	0.30 kg in 100 kg

Ingredient Name	Strength
Inactive Ingredients
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
HYDANTOIN (UNII: I6208298TA)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50241-020-01	3.91 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/12/2015	12/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/12/2015	12/28/2022

Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)

Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)

Name	Address	ID/FEI	Business Operations
Establishment
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture(50241-020) , api manufacture(50241-020) , pack(50241-020)

Revised: 12/2022

Document Id: 9f0c0755-3c3f-497e-9c48-274ccab359f7

Set id: 733b5ee5-76e2-4945-8d87-13e4e760f1d0

Version: 2

Effective Time: 20221228

Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.