ALCOHOL-FREE HAND SANITIZING FOAM- benzalkonium chloride solution

Alcohol-Free Hand Sanitizing Foam by

Drug Labeling and Warnings

Alcohol-Free Hand Sanitizing Foam by is a Otc medication manufactured, distributed, or labeled by United Laboratories Inc., Woodbine Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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 productavoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor ifirritation or redness develops, or if condition persists for more than 72 hours.

Keep out of the 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 and fragrance.

PRINCIPAL DISPLAY PANEL - 2 Ounce Bottle Label

UNITED
LABORATORIES

United 764

MICROMOUSSE

Alcohol-Free
Hand Sanitizing Foam

2 FLUID OUNCES

Eliminates 99.99% of common
disease-causing germs.

Made in USA
1018

UNITED LABORATORIES, INC.
320 37th Avenue St. Charles, IL 60174
1-800-323-2594 www.unitedlabsinc.com

INGREDIENTS AND APPEARANCE

ALCOHOL-FREE HAND SANITIZING FOAM 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63998-764
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)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63998-764-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
2	NDC: 63998-764-02	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/01/2019

Labeler - United Laboratories Inc. (001759737)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(63998-764)