GENTLE HAND SANITIZER- benzalkonium chloride spray

GENTLE HAND SANITIZER by

Drug Labeling and Warnings

GENTLE HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Nature's Organics, LLC, Health Specialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.1%

PURPOSE

ANTIMICROBIAL

USES

For hand sanitizing to reduce bacteria on the skin. Recommended for repeated use.

WARNINGS

For external use only.

Avoid direct contact with eyes. In case of eye contact, please flush the eyes with water.

Contact a doctor if irritation or redness persists.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help and/or contact a poison control center immediately.

DIRECTIONS

Spray the hands and rub together briskly to cover all surfaces.

INACTIVE INGREDIENTS

Water, Phenoxyethanol, Benzoic Acid, Ethylhexyl-glycerin, Glycereth-2 Cocoate, Dihydroxypropyl PEG-5, Linoleammonium Chloride, Behetrimonium Chloride, Potassium Hydroxide, Dihydroxyethyl Cocamine Oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENTLE HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73725-110
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73725-110-11	113.4 g in 1 BOTTLE; Type 0: Not a Combination Product	03/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/25/2020

Labeler - Nature's Organics, LLC (052224117)

Registrant - Nature's Organics, LLC (052224117)

Establishment
Name	Address	ID/FEI	Business Operations
Health Specialty		794053863	manufacture(73725-110)