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NDC 59088-0315-16 GenRx Hand Sanitizing 1.3 mg/mL Details

GenRx Hand Sanitizing 1.3 mg/mL

GenRx Hand Sanitizing is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	59088-0315
Product ID	59088-315_a12715c0-77f3-7716-e053-2995a90a06d3
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	GenRx Hand Sanitizing
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	PureTek Corporation
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 59088-0315-16 (59088031516)

Pricing Information	N/A
NDC Package Code	59088-315-16
Billing NDC	59088031516
Package	237 mL in 1 BOTTLE, SPRAY (59088-315-16)
Marketing Start Date	2020-03-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a12715c0-77f2-7716-e053-2995a90a06d3 Details

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

■ a topical antiseptic that protects against germs

Warnings

For external use only

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ Irritation and redness develop

■ 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

■ wet hands thoroughly with product

■ allow to dry without wiping

■ repeat as necessary

Other information

■ protect from freezing ■ avoid excessive heat

Inactive ingredients

Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, disodium EDTA, glycerin, phenoxyethanol,

purified water, sodium hyaluronate.

GenRx Hand Sanitizing Spray (8 oz label)

INGREDIENTS AND APPEARANCE

GENRX HAND SANITIZING

benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59088-315
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59088-315-16	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/18/2020

Labeler - PureTek Corporation (785961046)

Revised: 3/2020

Document Id: a12715c0-77f3-7716-e053-2995a90a06d3

Set id: a12715c0-77f2-7716-e053-2995a90a06d3

Version: 1

Effective Time: 20200318