Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3a50a833-2a3d-4d08-98f2-d442cf62715b
Route
DENTAL
Published
Effective Date 2012-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g) Nitrate Ion (5.0 g)
Inactive Ingredients
Water Saccharin Sodium Sodium Tripolyphosphate Polyethylene Glycol 400 Sorbitol Titanium Dioxide Sodium Hydroxide Glycerin Xanthan Gum Hydrated Silica Cocamidopropyl Betaine Sodium Methyl Cocoyl Taurate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-01-20

Description

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Purpose

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity


Medication Information

Warnings and Precautions

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Purpose

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Dosage and Administration

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Description

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities
Section 50565-1

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

mm1.jpg

mm2.jpg

Directions

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive Ingredients

cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

Active Ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity


Structured Label Content

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities
Dosage and Administration (34068-7)

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Warnings and Precautions (34071-1)

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

mm1.jpg

mm2.jpg

Directions

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive Ingredients (Inactive ingredients)

cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

Active Ingredients / Purpose (Active ingredients / Purpose)

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)