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Drug Facts
Rhinomel Manuka Spray
FDA Label NDC 73024-474
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melcare Biomedical Pty Ltd for the product Rhinomel Manuka (NDC 73024-474). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Sodium chloride
Purpose
Nasal Wash
Uses
For persons prone to congestion
Warnings
• Do not use if hyper-sensitive
to bee products, pollens or the
preservative benzoic acid;
• Not suitable for persons with
irritated nasal linings or
suspected sinus infection. The
natural acidity of honey may
result in transient discomfort;
• For any reaction other than
transient discomfort cease use
and contact your health care
professional;
• Consult your doctor if
symptoms persist for more
than 1 week, tend to reoccur
or are accompanied by pain or
a persistent headache. These
could be signs of a serious
condition;
• Not recommended for
pregnant women or children
under 12 years without
medical advice;
• Replace cap after use;
• Do not use if packaging is
damaged or carton tamper
seal is broken before first use.
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children
Directions
• Adults and Children
ages over 12.
• Remove cap.
• Use 1-2 sprays per
nostril as needed.
• Direct nozzle into your
nostril. Fully depress the
pump once or twice.
Repeat in other nostril.
• After use, breathe
normally – avoid sniffing.
• Wipe nozzle with clean
dry tissue after use.
Other Information
- Single patient use only.
- Discard 2 months after opening.
- Store below 25°C (77°F)
Inactive Ingredients
Water, honey (Leptospermum spp), sodium gluconate, glycerine. Preservative sodium benzoate.
Questions?
Web: www.melcare.com
Email: [email protected]
Phone: 855 708 2611
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