TOPCARE SINUS NASAL- oxymetazoline hydrochloride 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.

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Topco Associates LLC. Sinus Nasal Spray Severe Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves

nasal congestion due to a cold, hay fever, or other upper respiratory allergies
sinus congestion and pressure

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
do not use this product 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 (1-800-222-1222).

Directions

Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. 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. Secure cap after use.

adults & children

6 yrs. & 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 solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO SINEX® SEVERE ACTIVE INGREDIENT

Sinus Nasal Spray

SEVERE

NASAL DECONGESTANT

OXYMETAZOLINE HCl 0.05%

WITH MENTHOL

ULTRA FINE MIST

12 HOUR RELIEF

• Sinus Congestion & Pressure

• Fast & Powerful Relief

1 FL OZ (30 mL)

sinus nasal spray-image
TOPCARE SINUS NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-711
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EUCALYPTOL (UNII: RV6J6604TK)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-711-101 in 1 CARTON07/17/2018
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/17/2018
Labeler - Topco Associates LLC (006935977)

Revised: 4/2023
Document Id: 920aa75e-60d5-4765-96c7-37708a540629
Set id: ca1fefed-e9d7-430a-9da4-972b1a6fb786
Version: 3
Effective Time: 20230403
 
Topco Associates LLC