SANI-SURE AF- benzalkonium chloride solution

Sani-Sure AF by

Drug Labeling and Warnings

Sani-Sure AF by is a Otc medication manufactured, distributed, or labeled by Whisk Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

• For hand sanitizing to decrease bacteria on the skin
• Recommended for repeated use

Warnings

For external use only.

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

Stop use and ask a doctor if irritation or redness develops, or if condition persists 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

• Pump a small amount of foam into palm of hand.
• Rub thoroughly over all surfaces of both hands.
• Rub hands together briskly until dry.

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Phenoxyethanol, Lauramine Oxide, Panthenol, Fragrance, Citric Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANI-SURE AF 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65585-360
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white (water white - colorless, dispensed as a white foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65585-360-01	4 in 1 BAG	09/04/2024
1		1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	09/04/2024

Labeler - Whisk Products, Inc. (834270639)

Establishment
Name	Address	ID/FEI	Business Operations
Whisk Products, Inc.		834270639	manufacture(65585-360)