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- NDC Code(s): 36800-907-10
- 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)
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- Active ingredient
Oxymetazoline hydrochloride 0.05%
- Purpose
- Uses
- •
- temporarily relieves nasal congestion due to:
- •
- common cold
- •
- hay fever
- •
- upper respiratory allergies
- •
- temporarily relieves sinus congestion and pressure
- •
- shrinks swollen nasal membranes so you can breathe more freely
- Warnings
Ask a doctor before use if you have
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- 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
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
- •
- 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 Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.
- 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, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water
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- INGREDIENTS AND APPEARANCE
TOPCARE NASAL
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-907 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 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) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 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:36800-907-10 1 in 1 CARTON 07/14/2016 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 07/14/2016 Labeler -Topco Associates LLC(006935977)
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Safety
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More Info on this Drug
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View Labeling Archives for this drug
TOPCARE NASAL- oxymetazoline hydrochloride spray
Number of versions: 4
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Jun 2, 2023 | 4 (current) | download |
| Dec 4, 2019 | 3 | download |
| Jul 25, 2018 | 2 | download |
| Jul 20, 2016 | 1 | download |
RxNorm
TOPCARE 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 NASAL- oxymetazoline hydrochloride spray
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NDC Codes
TOPCARE 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 | 36800-907-10 |
