Active Ingredient(S)
Sodium Chloride (0.9%)
Athomer Baby
FDA Label NDC 80897-002
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 Baby (NDC 80897-002). 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, 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:
- Suitable for repeated long-term use
- Shake well before each use
apply 1 to 2 sprayings in each nostril every day
Warnings
- Use only as directed
- The use of this dispenser by more than one person may spread infection
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Other Information
- Store at room temperature between 68° and 77° F (20° to 25°C)
Inactive Ingredients
Sea Water
Package Label - Principal Display Panel
100 ml NDC: 80897-002-10
Inner Bottle Label (Athomer Baby Cimke)
Outer Package Label (Athomer Baby Doboz)
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