SPL v2
SPL
SPL Set ID 53a756e4-505b-6042-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2017-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (5 g)
Inactive Ingredients
Leuconostoc/radish Root Ferment Filtrate Coco Glucoside Calcium Carbonate Sorbitol Xylitol Glycerin Water Hydrated Silica Xanthan Gum Mentha Spicata Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-07-06
Description

Active ingredients Postassium nitrate, 5%

Medication Information

Warnings and Precautions

Warnings

When using this product, if pain/sensitivity still persists after 4 weeks or use, please visit your dentist

Indications and Usage

Use builds increasing protection against painful sensitivity of the teeth to cold, acids, sweets, or contact

Dosage and Administration

Directions

  • adults and children 12 years of age and older
  • Apply at least a 1-inch strip of the product onto soft bristle toothbrush
  • Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist
  • Make sure to brush all sensitive areas of the teeth
  • Children under 12 years of age: consult a dentist or doctor
Description

Active ingredients Postassium nitrate, 5%

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 51727-6

Inactive ingredients

Calcium carbonate, Sorbitol, Agua, Glycerin, Hydrate Silica, Xynthol, Coco-glucoside, Xanthan Gum, Mentha Viridis (Spearmint) Leaf Oil, Menthol, Leuconostoc/Radish Root Ferment Filtrate

Section 51945-4

Section 55105-1

Purpose

Antisensitivity

Section 55106-9

Active ingredients

Postassium nitrate, 5%

Structured Label Content

Indications and Usage (34067-9)

Use builds increasing protection against painful sensitivity of the teeth to cold, acids, sweets, or contact

Dosage and Administration (34068-7)

Directions

  • adults and children 12 years of age and older
  • Apply at least a 1-inch strip of the product onto soft bristle toothbrush
  • Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist
  • Make sure to brush all sensitive areas of the teeth
  • Children under 12 years of age: consult a dentist or doctor
Warnings and Precautions (34071-1)

Warnings

When using this product, if pain/sensitivity still persists after 4 weeks or use, please visit your 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 51727-6 (51727-6)

Inactive ingredients

Calcium carbonate, Sorbitol, Agua, Glycerin, Hydrate Silica, Xynthol, Coco-glucoside, Xanthan Gum, Mentha Viridis (Spearmint) Leaf Oil, Menthol, Leuconostoc/Radish Root Ferment Filtrate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antisensitivity

Section 55106-9 (55106-9)

Active ingredients

Postassium nitrate, 5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:24.178455 · Updated: 2026-03-14T22:54:50.171645