NASAL- oxymetazoline hydrochloride kit

nasal by

Drug Labeling and Warnings

nasal by is a Otc medication manufactured, distributed, or labeled by DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                   Purpose

   Oxymetazoline hydrochloride 0.05% Nasal Decongestant

Uses

For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies.
temporary relieves sinus congestion and pressure
shrinks swollen nasal membranes so you can breathe more freely

PURPOSE

Warnings

Ask a doctor before use if you have

heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland

When using this product

do not use more than directed
do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
use of this container by more than one person may spread infection.
Stop use and ask a doctor if symptoms persist.
If pregnant or breast feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
Children under 6 years of age: ask a doctor.
To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Other information
store at room temperature.

Inactive ingredients

Benzalkonium Chloride, benzyl Alcohol, edetate disodium, polyethylene glycol, Povidone, propylene glycol, Purified water, Sodium Phosphate dibasic, Sodium Phosphate monobasic.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NASAL 
oxymetazoline hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73169-002

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73169-002-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	06/07/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		1
Part 2		1
Part 3		1
Part 4		1

Part 1 of 4

NO MORE NOSEBLEED 
oxymetazoline hydrochloride liquid

Product Information
Item Code (Source)	NDC: 73169-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341

Part 2 of 4

SODIUM CHLORIDE 0.65% - NASALSALINE SPRAY 
moisturizing

Product Information

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 3 of 4

VASELINE PETROLEUM JELLY 
moisturizing

Product Information

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 4 of 4

BLEEDCEASE 
other personal cleanliness products

Product Information

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/07/2019

Labeler - DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. (117075364)

Registrant - DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. (117075364)

Establishment
Name	Address	ID/FEI	Business Operations
DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.		117075364	manufacture(73169-002)