First Street Antimicrobial Hand Wash

First Street Antimicrobial Hand Wash by

Drug Labeling and Warnings

First Street Antimicrobial Hand Wash by is a Otc medication manufactured, distributed, or labeled by Amerifoods Trading Company, Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FIRST STREET ANTIMICROBIAL HAND WASH- chloroxylenol soap 
Amerifoods Trading Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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First Street Antimicrobial Hand Wash

Active Ingredient

Chloroxylenol 0.3% 

Inactive Ingredients

2-Methyl-4-Isothiazolin-3-One, 5-Chloro-2Methyl-4-Isothizolin-3-One, Cocamide MIPA, Cocamidopropyl Betaine, FD&C Red No.40, FD&C Yellow No. 5, Fragrance, Glycerin, Sodium Chloride, Sodium Laurel Sulfate, Water

Purpose

Antimicrobial

Uses

• For hand washing to decrease bacteria on the skin
• recommended for repeated use

Warning

• For external use only
• Do not use in or near eyes

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

• Wet hands and forearms
• Apply 5 milliliters (teaspoonful or palmful) to hands and forarms
• Scrub thoroughly for 15 seconds

First Street Liquid Antimicrobial Hand Soap

FIRST STREET ANTIMICROBIAL HAND WASH 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61504-501
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
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61504-501-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2023
2	NDC: 61504-501-64	1893 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2023
3	NDC: 61504-501-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/29/2023	07/15/2024

Labeler - Amerifoods Trading Company (626388680)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture(61504-501) , api manufacture(61504-501) , pack(61504-501)

Revised: 1/2024

Document Id: bf9f2645-1fbe-4f53-a728-a169bdbba969

34390-5

Set id: 33a13204-963f-48db-b29b-89598221aea2

Version: 2

Effective Time: 20240112