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NDC 50353-0105-50 Purmist 0.13 g/mL Details

Purmist 0.13 g/mL

Purmist is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by MKR International Inc. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	50353-0105
Product ID	50353-105_e0546876-966a-a2de-e053-2995a90ad17b
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	Purmist
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Cl
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	MKR International Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50353-0105-50 (50353010550)

Pricing Information	N/A
NDC Package Code	50353-105-50
Billing NDC	50353010550
Package	60 mL in 1 BOTTLE, SPRAY (50353-105-50)
Marketing Start Date	2021-04-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dbd86ed2-3bcc-67cd-e053-2995a90a9697 Details

Active Ingredient

Benzalkonium Cl 0.13%

Purpose

Antiseptic

Uses

Leave on hand sanitizer to decrease harmful bacteria on the skin.

Warnings

For external use only.

DO NOT USE

in or near eyes.

Stop use and ask a doctor if

redness or irritation develop or persist for more than 72 hours.

Keep out of reach of children

unless under adult supervision. If swallowed get medical help or contact a Poison Control Center right away.

Directions

Spray as neeeded
Rub hands together covering all areas, including fingernail areas thoroughly

Other Information

store at 2ºC to 40ºC (35.6ºF to 104ºF)

Inactive Ingredients

polysorbate 80, proprietary blend of natural botanical oils, water

Dosage & Administration

300+ Sprays

Principal Display Panel

INGREDIENTS AND APPEARANCE

PURMIST

benzalkonium cl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50353-105
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50353-105-50	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/26/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/26/2021

Labeler - MKR International Inc (243605685)

Name	Address	ID/FEI	Business Operations
Establishment
McKenna Labs Inc		090631412	manufacture(50353-105)

Revised: 4/2022

Document Id: e0546876-966a-a2de-e053-2995a90ad17b

Set id: dbd86ed2-3bcc-67cd-e053-2995a90a9697

Version: 7

Effective Time: 20220407