INSTANT HAND ANTISEPTIC- benzalkonium chloride gel

Instant Hand Antiseptic by

Drug Labeling and Warnings

Instant Hand Antiseptic by is a Otc medication manufactured, distributed, or labeled by ASP Global, LLc, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.095%

Propose

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

Water, Polyquatemium-37, Glycerin, Propylene Glycol, Methylisothiazolinone, Trithanolamine.

SPL UNCLASSIFIED SECTION

Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway
Atlanta, GA 30331

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

ASP
MEDICAL

Instant Hand Antiseptic

Alcohol & Fragrance Free

1.9 FL OZ / 53 mL

Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway
Atlanta, GA 30331

Rev 00

INGREDIENTS AND APPEARANCE

INSTANT HAND ANTISEPTIC 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59448-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.095 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-003-01	53 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/27/2018

Labeler - ASP Global, LLc (080361159)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	MANUFACTURE(59448-003)