Dr. Sheffield Sensitive Care

Dr. Sheffield Sensitive Care
SPL v3
SPL
SPL Set ID 702a0dec-64cf-4834-8d80-f3d4f0c08a3a
Route
ORAL
Published
Effective Date 2023-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg)
Inactive Ingredients
Calcium Phosphate, Dibasic, Dihydrate Water Glycerin Calcium Carbonate Coconut Oil Quillaja Saponaria Wood Aloe Vera Leaf Xylitol Carrageenan Xanthan Gum Stevia Rebaudiuna Leaf Yucca Schidigera Root Smilax Aristolochiifolia Root Dioscorea Villosa Root Iris Germanica Var. Florentina Root Propolis Wax Melaleuca Alternifolia Leaf Commiphora Myrrha Top

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-05-15

Description

Potassium Nitrate 5%

Purpose

Tooth desensitizer


Medication Information

Purpose

Tooth desensitizer

Description

Potassium Nitrate 5%

Uses

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Section 50565-1

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.

Drug Fact

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.

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.

Active Ingredient

Potassium Nitrate 5%

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)


Structured Label Content

Uses

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Section 50565-1 (50565-1)

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.

Purpose

Tooth desensitizer

Drug Fact

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.

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.

Active Ingredient

Potassium Nitrate 5%

Inactive Ingredients (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 (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 (Principal Primary Panel Carton 5.0 oz)

Dr. Sheffield Certifed Natural Tooth Paste 

Sensitive Care Natural Mint Flavor

NET WT. 5 oz ( 141g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)