Label: TOPCARE NASAL SPRAY- oxymetazoline hydrochloride spray
- NDC Code(s): 36800-817-10
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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
Oxymetazoline HCl 0.05%Close
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- shrinks swollen nasal membranes so you can breathe more freely
Ask a doctor before use if you have
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an 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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- 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.Close
- Other information
- store at 20°-25°C (68°-77°F)
- retain carton for future reference on full labeling
- Inactive ingredients
benzalkonium chloride solution, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasicClose
- Principal Display Panel
Oxymetazoline Hydrochloride 0.05%
12 Hour Relief
Fast, powerful congestion relief
Relieves painful sinus pressure
Compare to Afrin® Sinus Nasal Spray active ingredient
Nasal Spray Carton
- INGREDIENTS AND APPEARANCE
TOPCARE NASAL SPRAY
oxymetazoline hydrochloride spray
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-817 Route of Administration NASAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 0.05 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-817-10 1 in 1 CARTON 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/06/1996 Labeler - Topco Associates LLC (006935977)