ALCOHOL FREE HAND SANITIZER- benzalkonium chloride solution
Hybrisan Ltd

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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Hybrisan Alcohol Free Aloe Vera & Cuccumber Hand Sanitizer

Drug Facts

Benzalkonium Chloride 0.13% Purpose Antiseptic

Drug Facts

Antiseptic

Drug Facts

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

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

Warnings

When using this product avoid contact with eyes. In case of eye contact flush eyes with water.

Ask Doctor

Stop use and ask a doctor if irritation and redness develop

Inactive ingredients

Fragrances, water

Directions

Apply liberally to the hands and gently rub until dry

Questions?

Telephone: 44-1639-898150 Monday through Friday 8:00am til 4:30pm UK time

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Package quantity

Gwalia Hybrisan 100ml Hand Sanitizer Bottle Front view 100ml (3.38 Floz) NDC 81685-321-10

ALCOHOL FREE HAND SANITIZER
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81685-321
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
3A,4,5,6,7,7A-HEXAHYDRO-1H-4,7-METHANOINDEN-6-YL ACETATE (UNII: 5232EN3X2F)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.ALPHA.-TERPINEOL (UNII: 21334LVV8W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)

Product Characteristics
Color	yellow (Clear liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81685-321-10	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/23/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/23/2021

Labeler - Hybrisan Ltd (219599200)

Name	Address	ID/FEI	Business Operations
Establishment
Hybrisan Ltd		219599200	manufacture(81685-321)

Name	Address	ID/FEI	Business Operations
Establishment
Gwalia Healthcare Limited		220632253	pack(81685-321)