FDA Label for Topcare No Drip Extra Moisturizing
View Indications, Usage & Precautions
Topcare No Drip Extra Moisturizing Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Fact
Active Ingredient
Oxymetazoline Hydrochloride 0.05%
Purpose
Nasal Decongestant
Uses
Temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiroty allergies
- temporarily relieves sinus congestion and pressure
- Shrinks swollen membranes so you can breathe more freely
Ask A Doctor Before Use If You Have
- heart diease
- high blood pressure
- diabetes
- thyiod diease
- trouble urinating due to enlarged rostate gland.
When Using This Product
- Do not use more than directed
- do not use for more than three 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 The Reach Of Children
if swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Before using for the first time, remove the protective cap form the tip and prime the 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 nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
- Wipe nozzle clean after use.
- Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
- Children under 6 years of age consult a doctor.
Other Information
store between 20° and 25°C (68° to 77°F)
retain carton for future reference on full labeling
Inactive Ingredients
Benzalkonium Chloride Solution, Benzyl Alcohol, Edetate Disodium, Flavor, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol, Povidone, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic
Principal Panel -Bottle Label
TOPCO NDC 36800-561-30
No Drip
Nasal Spray
Oxymetazoline HCL 0.05%Extra Moisturizing
NasaL Decongestant
NET WT 1 FL.OZ (30ml)
Principal Panel -Carton Label
TOPCO NDC 36800-561-30
No Drip
Nasal Spray
Oxymetazoline HCL 0.05%Extra Moisturizing
NasaL Decongestant
NET WT 1 FL.OZ (30ml)
* Please review the disclaimer below.