FDA.reportPublic FDA data

Sterile Saline Kids Mist

Manufacturer
KADENCE HEALTHCARE, INC.
Effective date
2022-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:58:06

Label at a glance#

ProductSterile Saline Kids Mist SinuCleanse Breathe
Active ingredientSODIUM CHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 0.9%

Sterile, Hypertonic Saline Solution,

Sodium Bicarbonate to adjust pH

Purpose

OTC - PURPOSE SECTION

Nasal Wash

Uses

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Warnings

WARNINGS SECTION

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

Other Information

OTHER SAFETY INFORMATION

Store between 59 and 86 degree F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purfied Water

QUESTIONS ?

OTC - QUESTIONS SECTION

1-888-547-5492

Saline Nasal Spray product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46011-000146011-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e5c5ca4c-28c6-c450-e053-2995a90a3075e265aae2-5a8b-35ef-e053-2a95a90a1a512022-08-08WarningsExact identifier
spl set id: e265aae2-5a8b-35ef-e053-2a95a90a1a51

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.