INSTANT HAND SANITIZER- benzalkonium chloride gel
Fun Zone, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Instant Hand Sanitizer 1.2oz

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.

image of bottle front label

image of bottle back label

INSTANT HAND SANITIZER
benzalkonium chloride gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Fun Zone, Inc. (803572929)