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Drug Facts
Zicam Intense Sinus Relief Spray
FDA Label NDC 10237-471
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Zicam Intense Sinus Relief (NDC 10237-471). 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 other, active ingredient, purpose, uses, ask a doctor before use if you have, when using this product, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Oxymetazoline hydrochloride 0.05%
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to:
- the common cold
- hay fever
- upper respiratory allergies
- temporarily relieves sinus congestion and pressure
- helps clear nasal passages
- shrinks swollen membranes
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 result
- use of this container by more than one person may spread infection
Otc - Stop Use
Stop use and ask a doctor if symptoms persist
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 open, hold the actuator to squeeze and turn cap
- hold with thumb at bottom of bottle and nozzle between fingers
- before using the first time, prime pump by depressing several times
- place tip of nozzle just past nasal opening (approximately 1/8")
- pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
- wipe nozzle clean after use
- to close, turn cap until it 'clicks'
To use pump:
Other Information
- store between 15-29°C (59-84°F)
- retain carton for future reference on full labeling
Inactive Ingredients
aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, dl-alpha tocopherol, eucalyptol, glycerin, hydroxyethylcellulose, hydroxylated lecithin, menthol, monosodium phosphate, polysorbate 80, purified water
Questions? Comments?
call 877-942-2626 toll free
www.zicam.com
Principal Display Panel - 15 Ml Bottle Carton
ZICAM®
INTENSE
SINUS
RELIEF
OXYMETAZOLINE HCl 0.05%
NASAL DECONGESTANT
12
HOUR
RELIEF
COLDS*ALLERGIES
Maximum Strength
Relief of Sinus
Pressure
No-Drip Liquid
®
NASAL SPRAY
Cooling
Menthol & Eucalyptus
0.50 FL OZ (15 mL)
* Please review the disclaimer below.
