- Label RSS
Drug Label Info
Safety
- Report Adverse Events
- FDA Safety Recalls
- Presence in Breast Milk
Related Resources
- Medline Plus
- Clinical Trials
- PubMed
- All Citations
- Adverse Effects
- Therapeutic Use
- Pharmacology
- Clinical Trials
- Biochemical Data Summary
More Info For This Drug
- View Labeling Archives
- RxNorm
- Get Label RSS Feed
- View NDC Code(s)NEW!
- NDC Code(s): 36800-711-10
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 3, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
View All Sections
- Active ingredient
Oxymetazoline HCl 0.05%
- Purpose
- 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
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)
- INGREDIENTS AND APPEARANCE
TOPCARE SINUS NASAL
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-711 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE .05g in100mL Inactive Ingredients Ingredient Name Strength 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 Color WHITE (off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-711-10 1 in 1 CARTON 07/17/2018 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/17/2018 Labeler -Topco Associates LLC(006935977)
View All Sections
Find additional resources
(also available in the left menu)
Safety
Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
TOPCARE SINUS NASAL- oxymetazoline hydrochloride spray
Number of versions: 3
Published Date (What is this?) | Version | Files |
---|---|---|
May 4, 2023 | 3 (current) | download |
Dec 5, 2019 | 2 | download |
Jul 25, 2018 | 1 | download |
RxNorm
TOPCARE SINUS NASAL- oxymetazoline hydrochloride spray
RxCUI | RxNorm NAME | RxTTY | |
---|---|---|---|
1 | 1000990 | oxymetazoline HCl 0.05 % Nasal Spray | PSN |
2 | 1000990 | oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray | SCD |
3 | 1000990 | oxymetazoline hydrochloride 0.05 % Nasal Spray | SY |
Get Label RSS Feed for this Drug
TOPCARE SINUS NASAL- oxymetazoline hydrochloride spray
To receive this label RSS feed
Copy the URL below and paste it into your RSS Reader application.
https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=ca1fefed-e9d7-430a-9da4-972b1a6fb786
To receive all DailyMed Updates for the last seven days
Copy the URL below and paste it into your RSS Reader application.
https://dailymed.nlm.nih.gov/dailymed/rss.cfm
What will I get with the DailyMed RSS feed?
DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.
How to discontinue the RSS feed
If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.
Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?
Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.
We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.
NDC Codes
TOPCARE SINUS NASAL- oxymetazoline hydrochloride spray
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 36800-711-10 |