Active Ingredient(S)
Sodium Chloride (0.9%)
Athomer Propolis
FDA Label NDC 80897-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nobu Baby Llc for the product Athomer Propolis (NDC 80897-001). 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(s), purpose, use, directions, warnings, otc - keep out of reach of children, other information or comments, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal decongestant
Use
- For cleaning the nasal cavity and the removal of the unpleasant mucus.
- For nasal irrigation
Directions
- For the liquidation and removal of the unpleasant mucus, apply at least 4 sprayings in each nostril up to 4 times per day
- For preventative daily use, apply 1 to 2 sprayings in each nostril every day
- Suitable for repeated long-term use
- Shake well before each use
Warnings
Use only as directed
The use of this dispenser by more than one person may spread infection
If you are pregnant or breastfeeding, seek guidance from a healthcare professional
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Information Or Comments
- Store at room temperature between 68° and 77° F (20° to 25°C)
Inactive Ingredients
Purified Water, Propolis
Package Label - Principal Display Panel
35 ml NDC: 80897-001-35
Inner Bottle Label (Propolis Cimke)
Outer Package Label (Propolis Doboz)
100 ml NDC: 80897-001-10
Inner Bottle Label Baby (Propolis Baby Cimke)
Outer Package Label Baby (Propolis Baby Doboz)
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