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.

----------

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

image description

FIRST STREET ANTIMICROBIAL HAND WASH
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61504-501
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/29/2023	07/15/2024

Labeler - Amerifoods Trading Company (626388680)

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