CLEANOTE SALINE NASAL SPRAYS- sodium chloride 0.9% aerosol, spray

Cleanote Saline Nasal Sprays by

Drug Labeling and Warnings

Cleanote Saline Nasal Sprays by is a Otc medication manufactured, distributed, or labeled by Cloudgoose Biology Science & Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Cleanote saline nasal spray

ACTIVE INGREDIENT

Sodium Chloride 0.9%

PURPOSE

Provide instant relief and a refreshing sensation to congested or dryirritated nasal passage due to cold, allergies, smoking, air pollution, dryair, and air travel. and use of decongestants/steroidal sprays.

INDICATIONS & USAGE

Provide instant relief and a refreshing sensation to congested or dryirritated nasal passage due to cold, allergies, smoking, air pollution, dryair, and air travel. and use of decongestants/steroidal sprays.

WARNINGS

lf pregnant or breast feeding, ask a health professional before use.Keep out of reach of children.

DO NOT USE

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

WHEN USING

adults and children 3 years oldand over.
press pump 6~8 times in eachnostril as often as needed or asdirected by physician.
children under 3 years old
press pump 1~2 times in eachnostril as often as needed or asdirected by physician.

STOP USE

lf pregnant or breast feeding, ask a health professional before use.

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

adults and children 3 years oldand over.
press pump 6~8 times in eachnostril as often as needed or asdirected by physician.
children under 3 years old
press pump 1~2 times in eachnostril as often as needed or asdirected by physician.

STORAGE AND HANDLING

store at room temperature

INACTIVE INGREDIENT

Peppermint oil

Eucalyptus oil
Benzalkonium chloride
Polysorbate 80
Purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEANOTE SALINE NASAL SPRAYS 
sodium chloride 0.9% aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83740-101
Route of Administration	INTRASINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	9 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
EUCALYPTUS OIL (UNII: 2R04ONI662)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83740-101-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2023
2	NDC: 83740-101-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2023
3	NDC: 83740-101-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/23/2023

Labeler - Cloudgoose Biology Science & Technology Co., Ltd. (420735544)

Registrant - Cloudgoose Biology Science & Technology Co., Ltd. (420735544)

Establishment
Name	Address	ID/FEI	Business Operations
Cloudgoose Biology Science & Technology Co., Ltd.		420735544	manufacture(83740-101)