Topcare No Drip Extra Moisturizing
FDA Label NDC 36800-561

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare No Drip Extra Moisturizing (NDC 36800-561). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug fact, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Fact

→ Purpose

→ Uses

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding

→ Keep Out Of The Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Panel -bottle Label

→ Principal Panel -carton Label

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