Alpha Alcohol Free Foaming Instant Hand Sanitizer by Whisk Products, Inc.

Alpha Alcohol Free Foaming Instant Hand Sanitizer by

Drug Labeling and Warnings

Alpha Alcohol Free Foaming Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Whisk Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALPHA ALCOHOL FREE FOAMING INSTANT HAND SANITIZER- benzalkonium chloride soap 
Whisk Products, 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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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, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance

ALPHA ALCOHOL FREE FOAMING INSTANT HAND SANITIZER 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65585-497
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.00 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	white (water white - 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: 65585-497-01	8 in 1 BOX	05/26/2009	03/20/2020
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 not final	part333E	05/26/2009	03/20/2020

Labeler - Whisk Products, Inc. (834270639)

Establishment
Name	Address	ID/FEI	Business Operations
Whisk Products, Inc.		834270639	manufacture(65585-497)

Revised: 3/2020

Document Id: d324725b-02ed-4815-a9ef-bf2d3f84063a

34390-5

Set id: 0692ec06-dc9a-4a35-abd5-933e661950e6

Version: 4

Effective Time: 20200320

 

Whisk Products, Inc.