TOPCARE SINUS RELIEF- oxymetazoline hcl spray 
Topco Associates LLC

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.

----------

Topco Sinus Relief Nasal Spray Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves nasal congestion due to

•
colds
•
hay fever
•
upper respiratory allergies

Warnings

Ask a doctor before use if you have

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

When using this product

•
do not exceed recommended dosage
•
use of this container by more than one person may spread infection
•
temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
•
do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

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. (1-800-222-1222)

Directions

Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.

adults and children 6 yrs and older (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 24 hours.

children 2 to under 6 yrs

ask a doctor

children under 2 yrs

do not use

Other information

•
store at 20°-25°C (68°-77°F)

Inactive ingredients

benzalkonium chloride, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, monobasic sodium phosphate, polysorbate 80, propylene glycol, purified water

Questions or comments?

1-888-423-0139

Principal Display Panel

See New Dosing Directions

12 Hour

Sinus Relief

Nasal Spray

Oxymetazoline HCl 0.05%

Nasal Decongestant

Ultra Fine Mist

With Soothing Vapors

Compare to Vicks® Sinex® 12 Hour Ultra Fine Mist active ingredient

Sinus Relief Nasal Spray Carton

Sinus Relief Nasal Spray Carton

Sinus Relief Nasal Spray Carton

TOPCARE SINUS RELIEF 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-688
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-688-051 in 1 CARTON07/29/200912/28/2017
114.7 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/29/200912/28/2017
Labeler - Topco Associates LLC (006935977)

Revised: 3/2018
Document Id: 64988486-c39b-48fa-ac7d-3fbd137f3307
Set id: e8576482-a704-4b75-8219-c178c028b18d
Version: 2
Effective Time: 20180328
 
Topco Associates LLC