INSTANT HAND ANTISEPTIC- benzalkonium chloride gel 
ASP Global, LLc

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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Instant Hand Antiseptic

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.095%

Purpose

Antiseptic

Uses

To help reduce bacteria on hands.

Warnings

For external use only.

When using this product avoid contact with eyes and lips. If contact occurs, rinse with water.

Stop use and ask a doctor if irritation or redness develops.

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

Directions

Rub dime sized amount between hands until dry.

Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Glycerin, Methylisothiazolinone, Propylene Glycol, Polyquaternium-37, Triethanolamine. Water

Distributed by :
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USA

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

ENGLEWOOD
HEALTH

Instant Hand Antiseptic

Alcohol & Fragrance Free

1.9 FL OZ / 53 mL

Distributed by :
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USA

Rev 03

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
INSTANT HAND ANTISEPTIC 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.095 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
Trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59448-002-0153 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2018
Labeler - ASP Global, LLc (080361159)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161MANUFACTURE(59448-002)

Revised: 12/2021
Document Id: 50b9b20a-6ccb-4d70-bc0c-b623adf6bba4
Set id: 4eef4b0f-9209-45a4-8a0e-7891fc380fe5
Version: 4
Effective Time: 20211229
 
ASP Global, LLc