INSTANT HAND SANITIZER- benzalkonium chloride gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fun Zone, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.095%

Purpose

Antiseptic

Use

To help reduce bacteria on hands.

Warnings

For external use only.

When using this product

• Avoid contact with eyes and lips.
• If contact occurs, rinse with water.

Stop using this product and consult a doctor If

irritation or redness develops.

Keep out of reach of children

If swallowed, get medical help or contact a poison control center immediately.

Directions

• Rub dime sized amount between hands until dry.
• For use by children under 6 years, adult supervision is required.

Inactive ingredients

Water, Polyquaternium-37, Glycerin, Propylene Glycol, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, Fragrance, Triethanolamine.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69583-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.95 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69583-035-01	35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/04/2020

Labeler - Fun Zone, Inc. (803572929)