Search by Drug Name or NDC

NDC 49035-0539-01 Equate Comfort Flow Sinus wash .515; 1.685 g/2.2g; g/2.2g Details

Equate Comfort Flow Sinus wash .515; 1.685 g/2.2g; g/2.2g

Equate Comfort Flow Sinus wash is a NASAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by WALMART INC. The primary component is SODIUM BICARBONATE; SODIUM CHLORIDE.

Product Information

NDC	49035-0539
Product ID	49035-539_e8822ba3-3d82-341e-e053-2995a90a31c0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Equate Comfort Flow Sinus wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	SINUS WASH
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER, FOR SOLUTION
Route	NASAL
Active Ingredient Strength	.515; 1.685
Active Ingredient Units	g/2.2g; g/2.2g
Substance Name	SODIUM BICARBONATE; SODIUM CHLORIDE
Labeler Name	WALMART INC
Pharmaceutical Class	Alkalinizing Activity [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 49035-0539-01 (49035053901)

Pricing Information	N/A
NDC Package Code	49035-539-01
Billing NDC	49035053901
Package	110 g in 1 BOX (49035-539-01)
Marketing Start Date	2020-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9e911eef-ca99-9902-e053-2a95a90aab0e Details

Active Ingredients

Sodium Bicarbonate USP 515 mg

Sodium Chloride USP 1685 mg

Purpose

Nasal Wash

Uses

Restores vital moisture to provide prompt relief for dry , crusted and inflamed nasal membranes due to chronic sinusitis, colds, low humidity, overuse of nasal decongestant drops and sprays, allergies, minor nose bleeds and other minor nasal irritations.
Temporarily relieves nasal stuffiness.
Reduces swelling of nasal passages; shrinks swollen membranes.
Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure.

Warnings

Do not exceed recommended dosage.
This product may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge.
The use of this container by more than one person may spread infection.

SPL UNCLASSIFIED SECTION

Keep out of reach of children

Directions

Adults and children 4 years and over : Use 1-2 packets per 240 ml up to every 2 hours as needed
Children under 4 years : Consult a physician

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# and expiration date

Inactive Ingredients

None

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUATE COMFORT FLOW SINUS WASH

sinus wash powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-539
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	0.515 g in 2.2 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	1.685 g in 2.2 g

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

Product Characteristics
Color	white (WHITE CRYSTALLINE GRANULE POWDER)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-539-01	110 g in 1 BOX; Type 1: Convenience Kit of Co-Package	06/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/15/2020

Labeler - WALMART INC (051957769)

Registrant - GURUNANDA, LLC (079671169)

Revised: 9/2022

Document Id: e8822ba3-3d82-341e-e053-2995a90a31c0

Set id: 9e911eef-ca99-9902-e053-2a95a90aab0e

Version: 4

Effective Time: 20220912