DR. SHEFFIELD SENSITIVE CARE- sensitive tooth paste paste, dentifrice

Dr. Sheffield Sensitive Care by

Drug Labeling and Warnings

Dr. Sheffield Sensitive Care by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Fact

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of Children, If more than used for brushing is accidently 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 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

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)

INGREDIENTS AND APPEARANCE

DR. SHEFFIELD SENSITIVE CARE 
sensitive tooth paste paste, dentifrice

Product 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)