NASAL- oxymetazoline hydrochloride 
DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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. 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.

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NASAL 
oxymetazoline hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73169-002
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73169-002-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package06/07/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 2
Part 3
Part 4
Part 1 of 4
NO MORE NOSEBLEED 
oxymetazoline hydrochloride liquid
Product Information
Item Code (Source)NDC:73169-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart341
Part 2 of 4
SODIUM CHLORIDE 0.65% - NASALSALINE SPRAY 
moisturizing
Product Information
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 3 of 4
VASELINE PETROLEUM JELLY 
moisturizing
Product Information
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 4 of 4
BLEEDCEASE 
other personal cleanliness products
Product Information
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/07/2019
Labeler - DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. (117075364)
Registrant - DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. (117075364)
Establishment
NameAddressID/FEIBusiness Operations
DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.117075364manufacture(73169-002)

Revised: 1/2021
Document Id: b9471c6a-40e4-2afb-e053-2a95a90a0bf4
Set id: 095ace11-6b1e-41bf-96e3-cbf8fddca3e3
Version: 2
Effective Time: 20210119
 
DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.