Nasal Spray
FDA Label NDC 37835-995

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Nasal (NDC 37835-995). 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

Other

Drug Facts

Active Ingredient

Oxymetazoline hydrochloride 0.05%

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

Otc - Stop Use

Stop use and ask a doctor ifsymptoms 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 spray: squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other Information

  • do not use if seal around cap is missing or damaged
  • save carton for complete information
  • store between 20° to 25°C (68°F and 77°F)

Inactive Ingredients

benzalkonium chloride solution, dibasic sodium phosphate, edetate disodium dihydrate, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water.

Questions?

call toll-free 1-800-935-6737

Distributed By:

BI-MART

Eugene, OR 97402

*This product is not manufactured or distributed by the owner of the registered trademark Afrin ®

* Please review the disclaimer below.