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- 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.
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- 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?
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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)
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Safety
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Related Resources
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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 |
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TOPCARE SINUS NASAL- oxymetazoline hydrochloride spray
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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 |
