Dr. Sheffield Sensitive Care Paste, Dentifrice
FDA Label NDC 11527-420
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product Dr. Sheffield Sensitive Care (NDC 11527-420). 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 fact, active ingredient, purpose, uses, warnings, directions, inactive ingredients, principal primary panel tube 5.0 oz, 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%
Purpose
Tooth desensitizer
Uses
Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.
Warnings
When using this product, if pain/sensivity still persists after 4 weeks of use, please ask your dentist.
Stop Use and ask a Dentist, if the problem persists or worsens, Sensitive teeth may indicate a serious problem that may neeed prompt care of a dentist.
When using this product, if pain/sensivity still persists after 4 weeks of use, stop use and contact your dentist.
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 doctor.
Make sure to brush all sensitive areas of the teeth.
Children under 12 years of age: consult a dentist or doctor.
Inactive Ingredients
Dicalcium Phosphate Dihydrate, Water (purified), Glycerin, Calcium Carbonate, Organic Cocos Nucifera (Coconut) oil, Quillaja Saponaria Wood Extract, Organic Aloe Barbadensis Leaf, Xylitol, Carrageenan, Xanthum Gum, Stevia Rebaudiana Leaf/Stem Extract, Yucca Schidigera Root extract, Quillaja Saponaria Bark Extract, Smilax Aristolochiaefolia Root extract, Dioscorea Villosa (Wild Yam) Root extract, Natural Peppermint flavor, Natural Menthol, Natural Spearmint Flavor, Natural Fennel Flavor, Iris Florentina (Orris) Root Powder, Propolis Extract, Organic Melaleuca Alternifolia(teatree) oil, Commiphora Myrrha (Myrrha) ResinExtract, Sodium Benzoate
Principal Primary Panel Tube 5.0 Oz
Dr. Sheffield Certifed Natural Toothpaste
Sensitive Care Natural Mint
NET WT. 5 OZ (141g)
Principal Primary Panel Carton 5.0 Oz
Dr. Sheffield Certifed Natural Tooth Paste
Sensitive Care Natural Mint Flavor
NET WT. 5 oz ( 141g)
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