Active Ingredient
Oxymetazoline hydrochloride 0.05%
Leader Spray
FDA Label NDC 70000-0766
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader (NDC 70000-0766). 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 active ingredient, 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 reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal Decongestant
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
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 at 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. Push down cap while turning 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. Replace clip under rim and secure cap after use.
Other Information
▪ store at room temperature
Inactive Ingredients
benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.
Package/Label Principal Display Panel
COMPARE TO AFRIN® NO DRIP ALLERGY SINUS active ingredient*
NDC# 70000-0766-1
NO DRIP
Allergy Sinus
Nasal Mist
Oxymetazoline HCl, 0.05%
Nasal Decongestant
Pump Mist
Up to 12 Hour Relief
Won’t Drip from nose or down throat
Fast, Powerful Congestion Relief from Allergies
Reduces swelling of Nasal Passages
1 FL OZ (30 mL)
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
1-800-200-6313
Essential to Care™ since 1979
IMPORTANT: Keep this carton for future reference on full labeling. |
TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING
* This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Allergy Sinus.
Leaderno Drip Allergy Sinus Nasal Mist 30ml (7j8el Nasal Spray)
* Please review the disclaimer below.
