First Street Antimicrobial Liquid Hand Soap

First Street Antimicrobial Liquid Hand by

Drug Labeling and Warnings

First Street Antimicrobial Liquid Hand by is a Otc medication manufactured, distributed, or labeled by Amerifoods Trading Co., Genlabs Corporation, Morgan Gallacher. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FIRST STREET ANTIMICROBIAL LIQUID HAND- chloroxylenol gel 
Amerifoods Trading Co.

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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First Street Antimicrobial Liquid Hand Soap

Drug Facts

Active ingredient

Chloroxylenol 0.25%

Purpose

Antiseptic

Uses

• for handwashing to decrease bacteria on the skin
• recommended for repeated use

Warnings

For external use only

Do not use

in the eyes. In case of contact, flush thoroughly with water.

Stop use and ask a doctor if

irritation and 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 and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 15 seconds. Rinse and repeat.

Inactive ingredients:

5-Chloro-2-Methyl-4-Isothiazolin-3-One, Cocamide MIPA, Cocamidopropyl Betaine, D&C Red #33, Fragrance, Glycerin, Glycol Distearate, 2-Methyl-4-Isothiazolin-3-One, Sodium Chloride, Sodium Laureth Sulfate, Water.

Package Labeling:

FIRST STREET ANTIMICROBIAL LIQUID HAND 
chloroxylenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61504-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	2.5 mg  in 0.001 L

Inactive Ingredients
Ingredient Name	Strength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61504-025-00	3.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2023	01/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/04/2023	01/06/2023

Labeler - Amerifoods Trading Co. (626388680)

Registrant - Genlabs Corporation (064594260)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher		028311595	manufacture(61504-025)

Revised: 2/2023

Document Id: f4be6979-d79b-9369-e053-2a95a90abd6b

34390-5

Set id: 9cc5b8e6-796b-4851-a6b4-ec41d48f45d9

Version: 2

Effective Time: 20230215