HAND SANITIZER PLUS HOLDER- benzalkonium chloride liquid

Hand Sanitizer plus Holder by

Drug Labeling and Warnings

Hand Sanitizer plus Holder by is a Otc medication manufactured, distributed, or labeled by Gertex Hosiery, Aocai Biotechnology Huizhou Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For External use only. 

Do not use

if you are allergic to any of the ingredients.

When using this product

do not get into eyes.  If contact occurs, rinse thoroughly with water.

­­­­­­­­­­­­­­­­­­­Stop use and ask a doctor.

If irritation or rash occurs develop and persist 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

-Adults and children 2 years and over.

-Rub on hands for 30 seconds and allow skin to dry.

-Children under 2 years.

-Ask a doctor before use.

Other Information

Store at 20-25C (68-77F)

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Polysorbate 20, Triethanolamine, Carbomer, Phenoxyethanol, Ethylhexylglycerin.

Hand Sanitizer + Holder

INGREDIENTS AND APPEARANCE

HAND SANITIZER PLUS HOLDER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78164-101
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 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CARBOMER (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78164-101-35	35 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/01/2025

Labeler - Gertex Hosiery (201658481)

Registrant - Gertex Hosiery (201658481)

Establishment
Name	Address	ID/FEI	Business Operations
Aocai Biotechnology Huizhou Co Ltd		722091830	manufacture(78164-101)