Otc - Active Ingredient
carbamide peroxide
Dr. Whitiss (8.3%)
FDA Label NDC 47649-9001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nibec Co., Ltd for the product Dr. Whitiss (8.3%) (NDC 47649-9001). 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
polyvinyl pyrrolidone (k=90), glycerin, anhydrous ethyl alcohol, distilled water, potassium dihydrogen phosphate, sodium hydroxide, lemon oil, orange oil, xylitol, l-menthol, potassium nitrate, propolis ext
Otc - Purpose
whitening of discolored vital teeth
Otc - Keep Out Of Reach Of Children
keep out of reach of the children
Indications & Usage
apply 2 or 3 times per day for 2 weeks for a brighter, whiter smile
Warnings
1) do not use on patient with sensitive to carbamide peroxide
2) do not use on patient with oral infection
3) no to be used by pregnant or lactating women or children under 18 years old
4) to be used under the supervision of a dentist
5) do not swallow this medication
Dosage & Administration
for dental use only
* Please review the disclaimer below.
