CVS SINUS WASH- sodium chloride, sodium bicarbonate kit

CVS Sinus Wash by

Drug Labeling and Warnings

CVS Sinus Wash by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

(in each prefilled bottle)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

ACTIVE INGREDIENT

Active ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

PURPOSE

Purpose

Nasal Wash

PURPOSE

Purpose

Nasal Wash

INDICATIONS & USAGE

Uses

Temporarily relieves symptoms associated with

sinusitis, cold, flu or allergies:

-Sneezing

-Runny nose

-Nasal stuffiness

-Post nasal drip

-Removes inhaled irritants (dust, pollen)

-Promotes nasal and sinus drainage

-Helps reduce swelling of nasal membranes

-Moisturizes dry nasal passages

WARNINGS

Warnings

Stop use and ask a doctor if washing is uncomfortable or

symptoms are not reduced.

Do not use unfiltered tap water. See instructions inside box

for proper water sources.

Do not use if nasal passages are completely blocked or if you

have an ear infection or blocked ears.

When using this product:

• Use by only one person
• Wash with soap and water after each use
• Do not heat in microwave
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Directions:

Adults and children 4 years and over:  use 1  -  2 packets per 8 fl. oz (240 mL) up to every 2 hours as needed

Children under 4 years:  Consult a physician

Prior to first use see enclosed instruction sheet for complete directions

OTHER SAFETY INFORMATION

Other information

• Inspect saline packets for integrity
• Do not use saline packets if open or torn
• Protect saline packets from excessive heat and moisture
• See saline packets or box for lot no. and expiration date
  

INACTIVE INGREDIENT

Inactive ingredients

(in each prefilled bottle)

Purified Water USP, Benzalkonium Chloride USP (Preservative)

Inactive ingredients

(in each packet)

None

QUESTIONS

Questions?

1-888-547-5492

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS SINUS WASH 
sodium chloride, sodium bicarbonate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-4807

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-4807-28	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	02/22/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKET	3000 mg
Part 2	1 BOTTLE	240 g

Part 1 of 2

SINUS WASH PACKET 
sodium bicarbonate, sodium chloride powder

Product Information
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	77.8 mg  in 100 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	22.8 mg  in 100 mg

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 in 1 KIT
1		3000 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/15/2019

Part 2 of 2

SINUS WASH PREFILLED BOTTLE 
sodium bicarbonate, sodium chloride solution

Product Information
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	22.2 mg  in 0.1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	77.8 mg  in 0.1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 KIT
1		240 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/22/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-4807)