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NDC 63998-0764-01 Alcohol-Free Hand Sanitizing Foam 1 mg/mL Details

Alcohol-Free Hand Sanitizing Foam 1 mg/mL

Alcohol-Free Hand Sanitizing Foam is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by United Laboratories Inc.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	63998-0764
Product ID	63998-764_63f98a4a-af4d-4deb-a37e-6b3aad06c3bc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Alcohol-Free Hand Sanitizing Foam
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	United Laboratories Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63998-0764-01 (63998076401)

Pricing Information	N/A
NDC Package Code	63998-764-01
Billing NDC	63998076401
Package	59 mL in 1 BOTTLE (63998-764-01)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4f5ddead-1868-45c2-9657-762c9ca3a0e2 Details

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 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 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

PRINCIPAL DISPLAY PANEL - 2 Ounce Bottle Label

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333E	01/01/2019

Labeler - United Laboratories Inc. (001759737)

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

Revised: 11/2020

Document Id: 63f98a4a-af4d-4deb-a37e-6b3aad06c3bc

Set id: 4f5ddead-1868-45c2-9657-762c9ca3a0e2

Version: 1

Effective Time: 20201109