CVS- sodium bicarbonate, sodium chloride solution

CVS by

Drug Labeling and Warnings

CVS by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

PURPOSE

Ready to Use

SINUS WASH

INACTIVE INGREDIENT

Inactive ingredients:

Purified Water ISP

Benzalkonium Chloride USP (Preservative)

WARNINGS

Warning: When Using Bottle With

Refill Packets Do Not Use Unfiltered

Tap Water.

Use either distilled, or sterile, or filered

water (using a filter with an absolute pore

size of 1 micron or smaller) or previously boiled

water (boil water 1 minute or 3 minutes

if at elevations above 6500 feet

then allow to cool to body temperature).

QUESTIONS

Questions or Comments

1-888-547-5492

DESCRIPTION

See Instruction Sheet Inside Box

for Complete Directions

and Proper Use

INSTRUCTIONS FOR USE

Sinus Wash

Pre-Filled Ready to Use

Saline Sinus Wash Kit

Instructions

DO NOT

SINUS WASH

WITH UNFILTERED

TAP WATER.

See important note*

for proper water

sources.

Read through entire instruction sheet

before using for the first time.

What is the Sinus Wash Kit?

The Sinus Wash Kit is an all natural

and medically proven method

for relieving allergies, nasal congestion, discomfort caused by dry air, sinus

infections, rhinitis of pregnancy and soothing irritated nasal passages. It

gently washes away mucus buildup from the nose and improves breathing.

Because it is gentle, it can be used up to every 2 hours as needed. Some

people use it as routinely as they brush their teeth while others use it only

on days when they need it.

* IMPORTANT NOTE

Do not sinus wash with unfiltered tap water. Use either distilled, or

sterile, or fi ltered (using a filter with an absolute pore size of 1 micron or

smaller) or previously boiled water (boil water 1 minute or 3 minutes if at

elevations above 6,500 feet, then allow to cool to body temperature).

Refill instructions for the Ready to Use

Sinus Wash Kit (with saline packets)

Read through entire section.

The Ready to Use Sinus Wash Kit can be used with the enclosed Saline

packets to make either an Isotonic or Hypertonic solution. Check with the

guide below or consult with your physician for best use.

An Isotonic solution creates a mild, less concentrated salt solution of 9 mg

of Sodium Chloride per mL of water, which has a similar salt concentration

of your body and may be more comfortable to use for some people initially

than a more concentrated Hypertonic solution.

A Hypertonic solution creates a higher, more concentrated salt solution

which is similar to the salt content of ocean water.

1. Wash your hands and make sure the bottle has been rinsed with water

that has been either distilled, sterilized, filtered or previously boiled.

2. Pour the pre-mixed saline dry ingredients into the Squeeze Bottle.

First-time users should start with 1 packet of the saline dry ingredients

to make an isotonic solution. As you become more accustomed to

the system, work up to using 2 full packets for a hypertonic solution.

Additional packets may be purchased from your nearest pharmacy.

3. Fill the bottle to the 8 oz line with proper water*.

4. Tighten the cap on the bottle securely, place one finger over the tip

of the cap and gently shake the bottle until the dry ingredients have

completely dissolved.

5. Lean over the sink with your head bent down so you are looking directly

into the basin. Place the tip of the cap up to the right nostril and gently

insert the tip so that it forms a comfortable seal. Aim the tip at the back

of your head, not at the top of your head. (continued on back)

Hints for a more comfortable nasal wash:

Begin using the Sinus Wash System slowly – especially with children. A full

pot or bottle of solution on each side is not necessary to receive the full benefit.

If the solution is too warm or too cold, the nasal wash will be uncomfortable.

If stinging or irritation occurs, try using 1 packet of dry ingredients per

pot or bottle. Gradually work up to using the solution at full strength using 2

full packets per bottle. Do not use less than 1 packet.

If you experience ear discomfort after use, try to blow your nose more gently

after the wash. If the problem persists, the openings of your Eustachian tubes

may be particularly wide and use of the system should be discontinued.

Breathe continuously through the mouth when using the Sinus Wash System

to avoid solution draining from the back of the nose into the mouth.

Some people experience irritation of the skin just inside the nostrils with

repeated nasal washing. Applying a thin layer of aloe to the inside of the

nostrils before or after the nasal wash will be soothing

KEEP OUT OF REACH OF CHILDREN

See Instruction Sheet Inside Box

DOSAGE & ADMINISTRATION

See Instruction Sheet Inside Box

INDICATIONS & USAGE

See Instruction Sheet Inside Box

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS 
sodium bicarbonate, sodium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-865
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	22.2 mg  in .1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	77.8 mg  in .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	NDC: 59779-865-00	240 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2016

Labeler - CVS Pharmacy (062312574)