SinuCleanse Breathe, Sterile Saline Kids Mist

Sterile Saline Kids Mist by

Drug Labeling and Warnings

Sterile Saline Kids Mist by is a Otc medication manufactured, distributed, or labeled by KADENCE HEALTHCARE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STERILE SALINE KIDS MIST SINUCLEANSE BREATHE- sodium chloride spray 
KADENCE HEALTHCARE, INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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SinuCleanse Breathe, Sterile Saline Kids Mist

Active Ingredient

Sodium Chloride 0.9%

Sterile, Hypertonic Saline Solution,

Sodium Bicarbonate to adjust pH

Purpose

Nasal Wash

Uses

• Nasal congestion
• Removes inhaled irritants (dust, dirt, pollen)
• Moisturizes dry nasal passages

Directions

Directions
Children 6 months and over: Use as often as needed
Children under 6 months: Consult a physician

Warnings

Warnings

Use of this product by more than one person may spread infection
Contents under pressure
Do not puncture or incinerate
Avoid spraying in eyes

Keep out of reach of chlidren.

Other Information

Store between 59 and 86 degree F

Inactive ingredients

Purfied Water

QUESTIONS ?

1-888-547-5492

Saline Nasal Spray product label

STERILE SALINE KIDS MIST  SINUCLEANSE BREATHE
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46011-0001
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	0.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46011-0001-1	127 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/13/2022	06/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/13/2022	06/13/2022

Labeler - KADENCE HEALTHCARE, INC. (784608650)

Revised: 8/2022

Document Id: e5c5ca4c-28c6-c450-e053-2995a90a3075

34390-5

Set id: e265aae2-5a8b-35ef-e053-2a95a90a1a51

Version: 2

Effective Time: 20220808