Active Ingredient
Active Ingredient: Sodium Fluoride 0.02%
Amhealer
FDA Label NDC 69890-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Healingam Co., Ltd for the product Amhealer (NDC 69890-010). 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, inactive ingredient, purpose, warnings, keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients: Water, Thiobacillus
Purpose
Purpose: Bad breath removal
Warnings
Warnings: 1. Keep out of reach of babies and children 2. Keep away from direct sunlight
Keep Out Of Reach Of Children
1. Keep out of reach of babies and children
Indications & Usage
Indications & Usage: Open the container cap and press the spray button(1~2 times)
Dosage & Administration
Dosage & Administration: Do not use more than 5㎖ per day (50 times)
* Please review the disclaimer below.
