Otc - Active Ingredient
active ingredient: hydrogen peroxide solution
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Premium Whitening
FDA Label NDC 60319-1001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hankuk Bowonbio Co., Ltd for the product Premium Whitening (NDC 60319-1001). 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 otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
inactive ingredient: polyvinyl alcohol, povidone, sodium stannate, purified water
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Otc - Purpose
for dental care use
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Otc - Keep Out Of Reach Of Children
keep out of reach of the children
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Indications & Usage
apply Proper Amount of the gel on the teeth.
Warnings
■ For tooth only.
■ Avoid contact with eyes.
■ Do not swallow. If swallowed, get medical help.
Dosage & Administration
* Please review the disclaimer below.
