Breathe The Sea
FDA Label NDC 52429-124

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nasal And Sinus Health, Inc. for the product Breathe The Sea (NDC 52429-124). 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 uses, directions, otc - do not use, otc - when using, caution, otc - keep out of reach of children, inactive ingredient, principal display panel - 125 ml canister label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

Helps dry congestion related to acute and chronic nasal stuffiness due to irritants, colds, occupational, environmental and home allergens. Provides comfort to congested nasal passages.

Directions

Tilt head forward, spray 2-3 times in each nostril directing spray upward and outward toward ear and away from center of nose. Blow nose. For a more thorough cleansing procedure see the Vanderpool Technique ™ and video demonstration at www.BreatheTheSea.com.

Otc - Do Not Use

Do not use with children under 6 years of age except as directed by a physician.

Do not use if tamper-evident seal is missing or torn from cap.

Otc - When Using

Use of this dispenser by more than one person may spread infection. Avoid spraying in eyes.

Caution

Contents under pressure. Do not puncture or incinerate. Store at room temperature (59-86°F). Avoid direct exposure to sunlight.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Inactive Ingredient

Active Ingredient: Seawater 80%

Inactive Ingredient: Purified water 20% Sterilized solution is 2.6% NaCl (sea salt)

Principal Display Panel - 125 Ml Canister Label

ALL NATURAL SEAWATER
SOLUTION
HYPERTONIC NASAL SPRAY

Breathe
the Sea™

The Every Day Nasal Spray™
Preservative Free

Use 2 – 4 times per day to:

  • Help Dry Congestion
    Due to Colds & Allergies
  • Breathe Easier
  • Soothe and Moisturize
  • Flush out Allergens & Irritants
  • Prewash Nasal Passages

    • 4.22 fl. oz. (125 mL)

    Principal Display Panel (125 mL Canister Label)

    Principal Display Panel (125 mL Canister Label)

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