NDC | 11527-420-45 |
Set ID | 702a0dec-64cf-4834-8d80-f3d4f0c08a3a |
Category | HUMAN OTC DRUG LABEL |
Packager | Sheffield Pharmaceuticals LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- Drug Fact
- Active Ingredient
- Purpose
- Uses
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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.
- KEEP OUT OF REACH OF CHILDREN
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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
- Questions? Call 1-800-222-1087
- Principal Primary Panel Tube 5.0 oz
- Principal Primary Panel Carton 5.0 oz
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INGREDIENTS AND APPEARANCE
DR. SHEFFIELD SENSITIVE CARE
sensitive tooth paste paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-420 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CALCIUM CARBONATE (UNII: H0G9379FGK) COCONUT OIL (UNII: Q9L0O73W7L) QUILLAJA SAPONARIA WOOD (UNII: 1L8K0593B6) ALOE VERA LEAF (UNII: ZY81Z83H0X) XYLITOL (UNII: VCQ006KQ1E) CARRAGEENAN (UNII: 5C69YCD2YJ) XANTHAN GUM (UNII: TTV12P4NEE) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT) SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0) DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD) PROPOLIS WAX (UNII: 6Y8XYV2NOF) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) COMMIPHORA MYRRHA TOP (UNII: N534J96ODY) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-420-45 1 in 1 CARTON 05/15/2017 1 141 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/15/2017 Labeler - Sheffield Pharmaceuticals LLC (151177797) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(11527-420)