SHSNH6-5111- benzalkonium chloride solution

SHSNH6-5111 by

Drug Labeling and Warnings

SHSNH6-5111 by is a Otc medication manufactured, distributed, or labeled by Shotwell Hydrogenics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients(s)

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use(s)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

For external use only.

Do not use

in children less than 2 months of age

on open skin wounds

When using this product avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask for a doctor if irritation or redness develops, 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

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands

Continue to rub hands until dry.

Inactive ingredients

deionized water, glycerin, aloe barbadensis leaf juice, lauramine oxide, dimethyltetradecylamine oxide, fragrance, DMDM hydantoin (preservative).

SPL UNCLASSIFIED SECTION

Alcohol-Free Foaming Hand Sanitizer

Antimicrobial Foaming Solution

Packaging

INGREDIENTS AND APPEARANCE

SHSNH6-5111 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73870-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
MYRISTAMINE OXIDE (UNII: J086PM3RRT)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73870-201-33	1249 L in 1 CONTAINER; Type 0: Not a Combination Product	10/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/05/2020

Labeler - Shotwell Hydrogenics, LLC (108985732)

Establishment
Name	Address	ID/FEI	Business Operations
Shotwell Hydrogenics, LLC		108985732	manufacture(73870-201)