ALCOHOL FREE HAND SANITIZER- benzalkonium chloride gel

Alcohol Free Hand Sanitizer by

Drug Labeling and Warnings

Alcohol Free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ayan Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

Keep out of eyes.  In case of contact with eyes, rinse with water.

Stop use and ask a doctor if

skin irritation and redness develops and persists.

Keep out of reach of children.

If swallowed, get medical help promptly and contact Poison Control Center.

Directions

Wet hands thoroughly with a product and allow to dry without wiping.

Other Information

Store under 105 o F. 

Inactive Ingredients

Water, Polyquaternium-10, Propylene Glycol, Glycerin, Polyaminopropyl Biguanide, PEG-40 Hydrogenated Castor Oil, Fragrance, Tromethamine

Package Labeling: 70412-150-10

Package Labeling: 70412-150-20

INGREDIENTS AND APPEARANCE

ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-150-10	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
2	NDC: 70412-150-20	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/30/2020

Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co.,Ltd.		544377996	manufacture(70412-150)