OPTIMAL HAND SANITIZER- benzalkonium chloride liquid

OPTIMAL Hand Sanitizer by

Drug Labeling and Warnings

OPTIMAL Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Optisource International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.1%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses  For hand sanitizing to decrease bacteria on the skin Recommended for repeat use

WARNINGS

Warnings
For external use only

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hrs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions  Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands Rub hands together briskly until dry.

INACTIVE INGREDIENT

Inactive ingredients Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

SPL UNCLASSIFIED SECTION

Alcohol-Free
Moisturizing

Kills 99.99% of Germs*

MADE IN USA

*of most common germs that may make you sick

Manufactured by: OptiSource International, Inc.

Bellport, NY 11713

Packaging

INGREDIENTS AND APPEARANCE

OPTIMAL HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75447-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75447-200-50	50 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/09/2020
2	NDC: 75447-200-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/09/2020	12/22/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/09/2020

Labeler - Optisource International Inc. (849200159)

Establishment
Name	Address	ID/FEI	Business Operations
Optisource International Inc.		849200159	manufacture(75447-200)