Sound Body 12 Hour Nasal
FDA Label NDC 23558-5120

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lee Pharmaceuticals for the product Sound Body 12 Hour Nasal (NDC 23558-5120). 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, directions, other information, inactive ingredients, 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: common cold, hay fever, sinusitis, upper respiratory allergies. 
  • Shrinks swollen membranes so you can breathe more freely.

Ask A Doctor Before Use If You Have

  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • 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.

Directions

  • Adults and children 6 to under 12 years of age (with adult supervision):  2 or 3 sprays in each nostril not more ofter 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.
  • To spray, squeeze bottle quickly and firmly.  Do not tilt head backwards while spraying. Wipe nozzle clean after use.

Other Information

  • Store between 20° - 25° C (68° - 77° F)
  • Retain carton for future reference on full labeling.

Inactive Ingredients

Benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

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