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NDC 69626-0064-05 Clear Mist 6.5 mg/mL Details

Clear Mist 6.5 mg/mL

Clear Mist is a NASAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Leosons Overseas Corp. The primary component is SODIUM CHLORIDE.

Product Information

NDC	69626-0064
Product ID	69626-0064_d3ac34fe-c663-23ed-e053-2a95a90aeb8b
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	Clear Mist
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	NASAL
Active Ingredient Strength	6.5
Active Ingredient Units	mg/mL
Substance Name	SODIUM CHLORIDE
Labeler Name	Leosons Overseas Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69626-0064-05 (69626006405)

Pricing Information	N/A
NDC Package Code	69626-0064-5
Billing NDC	69626006405
Package	1 BOTTLE, SPRAY in 1 CARTON (69626-0064-5) / 44 mL in 1 BOTTLE, SPRAY
Marketing Start Date	2016-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8d1b7ce5-6154-4b2d-8cd7-19fe74b1cfd6 Details

Drug Facts

Active ingredient & Purpose

Active ingredients	Purpose
Sodium chloride 0.65%	Moisturizer

Uses

For dry nasal membranes

Warnings

Do not use

if seal is broken or missing.

Keep out of reach of children.

The use of this dispenser by more than one person may spread infection.

Directions

squeeze twice in each nostril as needed
upright delivers a spray, horizontally a stream, upside down a drop

Inactive Ingredients

benzalkonium chloride, disodium phosphate, phenylcarbinol, monosodium phosphate, water.

Questions or comments?

Call toll-free at 1-855-452-9500 or email at [email protected]

Distributed by:

LEOSONS

10 Maryland Avenue

Albany, New York 12205

PRINCIPAL DISPLAY PANEL

Clear Mist ®

Saline

Nasal

Spray

Contains Sodium Chloride 0.65%

Alcohol Free

Bottle

Works 3 Ways

mist stream drops

Safe for all ages

Naturally soothes

nasal passages

INGREDIENTS AND APPEARANCE

CLEAR MIST

sodium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69626-0064
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69626-0064-8	1 in 1 CARTON	01/01/2016
1		88 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC:69626-0064-5	1 in 1 CARTON	01/01/2016
2		44 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	01/01/2016

Labeler - Leosons Overseas Corp (148605470)

Revised: 12/2021

Document Id: d3ac34fe-c663-23ed-e053-2a95a90aeb8b

Set id: 8d1b7ce5-6154-4b2d-8cd7-19fe74b1cfd6

Version: 2

Effective Time: 20211221