SPL v2
SPL
SPL Set ID 40be9fab-53db-c67a-e063-6394a90a48cb
Route
DENTAL
Published
Effective Date 2025-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (5 g)
Inactive Ingredients
Water Silica Mentha Viridis (spearmint) Leaf Oil Gaultheria Procumbens (wintergreen) Leaf Oil Hydrated Silica Sodium Benzoate Glycerin Sodium Lauroyl Sarcosinate Mentha Piperita (peppermint) Oil Xylitol Xanthan Gum Green Tea Leaf Sodium Bicarbonate Aloe Vera Leaf Juice Dimethyl Sulfone Sorbitol Mangifera Indica (mango) Fruit Avocado Cucumis Sativus (cucumber) Fruit Triacetin Star Anise Oil Stevia Rebaudiana Leaf Menthol Potassium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-09

Description

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.


Medication Information

Warnings and Precautions

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

Stop use and ask your dentistif the problem persists or worsens.

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.

Indications and Usage

Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

Dosage and Administration

Adults and children 12 years of age and older:Apply at least a 1-inch strip of the product onto a soft-bristled 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: Consult a dentist or doctor.

Description

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 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

Water, Glyercin, Hydrated Silica, Sorbitol, Silica, Hydroxyapatite (nano), Sodium Lauroyl Sarcosinate, Sodium Benzoate, Xantham Gum, Xylitol, Triacertin, Flavors, Potassium Chloride, Stevia Rebaudiana Leaf/Stem Extract, Dimethyl Sulfone, Peppermint (Mentha Piperita) Oil, Sodium Bicarbonate, Spearmint (Mentha Viridis) Leaf Oil, Menthol, Wintergreen (Gaulteria Procumbens) Leaf Oil, Anise (illicium Verum) Oil, Aloe Vera (Aloe Barbadensis) Leaf Juice, Green Tea (Camellia Sinensis) Leaf Extract, Cucumber (Cucumis Sativus) Fruit Extract, Mango (Mangifera Indica) Fruit Extract, Avocado (Persea Gratissma) Fruit Extract

Section 55105-1

Antisensitivty

Boka Sensitive 4.0 Oz Label Tube Packaging

Full Boka Sensitive 3.4oz Label Tube and Box Packaging


Structured Label Content

Indications and Usage (34067-9)

Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

Dosage and Administration (34068-7)

Adults and children 12 years of age and older:Apply at least a 1-inch strip of the product onto a soft-bristled 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: Consult a dentist or doctor.

Warnings and Precautions (34071-1)

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

Stop use and ask your dentistif the problem persists or worsens.

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 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)

Water, Glyercin, Hydrated Silica, Sorbitol, Silica, Hydroxyapatite (nano), Sodium Lauroyl Sarcosinate, Sodium Benzoate, Xantham Gum, Xylitol, Triacertin, Flavors, Potassium Chloride, Stevia Rebaudiana Leaf/Stem Extract, Dimethyl Sulfone, Peppermint (Mentha Piperita) Oil, Sodium Bicarbonate, Spearmint (Mentha Viridis) Leaf Oil, Menthol, Wintergreen (Gaulteria Procumbens) Leaf Oil, Anise (illicium Verum) Oil, Aloe Vera (Aloe Barbadensis) Leaf Juice, Green Tea (Camellia Sinensis) Leaf Extract, Cucumber (Cucumis Sativus) Fruit Extract, Mango (Mangifera Indica) Fruit Extract, Avocado (Persea Gratissma) Fruit Extract

Section 55105-1 (55105-1)

Antisensitivty

Boka Sensitive 4.0 Oz Label Tube Packaging (Boka Sensitive 4.0 oz Label Tube Packaging)

Full Boka Sensitive 3.4oz Label Tube and Box Packaging


Advanced Ingredient Data


Raw Label Data

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