Schmidts
FDA Label NDC 72916-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schmidt's Naturals for the product Schmidts (NDC 72916-210). 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 drug facts, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Potassium Nitrate (5%) w/w
Purpose
Tooth desensitizer
Use
Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Warnings
Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and older:
Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a Dentist or Physician. Make sure to brush all sensitive areas of the teeth.
Children under 12 years of age:
Consult a Dentist or Physician.
Inactive Ingredients
Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Natural Flavor, Sodium Methyl Cocoyl Taurate, Xanthan Gum, Magnolia Acuminata (Magnolia Bark) Extract, Lycium Barbarum (Goji Berry) Extract, Punica Granatum (Pomegranate) Seed Extract, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract, Mixed Tocopherols (Sunflower-derived), Stevia Rebaudiana Leaf/Stem Extract, Sodium Bicarbonate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Coenzyme Q10, Zinc Gluconate, Potassium Sorbate, Sodium Benzoate.
Questions:
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