FIRST STREET ANTIMICROBIAL HAND WASH- chloroxylenol soap

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]

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

INGREDIENTS AND APPEARANCE

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)