HAND SANITIZER SOLUTION 101- benzalkonium chloride liquid

Hand Sanitizer Solution 101 by

Drug Labeling and Warnings

Hand Sanitizer Solution 101 by is a Otc medication manufactured, distributed, or labeled by Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

No-Rinse E3 Hand Sanitizer -Gentle on the hands -Contains IPA for a Rapid Kill -Anti-Bacterial -Quick Drying -USDA & Kosher Aprroved -Contains Bezalkonium Chloride for Extended Protection Hand Sanitizer Solution #101 helps to reduce the level of bacteria on the skin DOT Shipping name: UN1219, Isopropyl alcohol solution,3, PG II

Active Ingredient

Benzalkoium Chloride.....0.13%

Purpose

Antimicrobial

Uses

For Hand Sanitizing to decrease bacteria on the skin

Warnings:

- For external use only

-Flammable keep away from fire or flame

​ ​When using this product

-Avoid contact with the eyes

In case of eye contact, flush eyes with water.

​Stop use and ask doctor if

--irritation or redness develops, if conditions persisit for more than 72 hours.

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

Directions

-Wash hands with soap and water Rinse with potable water- wet entire surface of hands with product especially the cuticles and fingernails -Rub hands together until dry - Do not rinse hands - Re-apply as needed

Inactive ingredients

Isopropyl Alcohol, Water

INGREDIENTS AND APPEARANCE

HAND SANITIZER SOLUTION 101 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50241-246
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50241-246-02	3.67 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 50241-246-01	4 in 1 BOX
2	NDC: 50241-246-08	202.07 kg in 1 DRUM; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/13/2015

Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)

Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture(50241-246) , api manufacture(50241-246) , pack(50241-246)