Wintergreen Peppermint Toothpaste

Wintergreen Peppermint Toothpaste
SPL v5
SPL
SPL Set ID 7b7beec2-e070-4102-a2a4-68c332fc9fb3
Route
DENTAL
Published
Effective Date 2021-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.5 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Sodium Tripolyphosphate Anhydrous Cocamidopropyl Betaine Methyl Salicylate Vitamin A Palmitate Tocopherol Aloe Vera Leaf Saccharin Sodium Sucralose Lauryl Glucoside Carboxymethylcellulose Sodium, Unspecified Titanium Dioxide Sodium Benzoate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01

Description

Potassium nitrate 5%. Sodium fluoride 0.240% (0.15% w/v fluoride ion).

Purpose

Antisensitivity Anticavity


Medication Information

Purpose

Antisensitivity

Anticavity

Description

Potassium nitrate 5%. Sodium fluoride 0.240% (0.15% w/v fluoride ion).

Uses
  • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • Aids in prevention of dental cavities.
Directions

• Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly after meals or at least twice a day or as recommended by a dentist or doctor. Make sure to brush sensitive areas of the teeth. Minimize swallowing.

• Children under 12 years: consult a dentist or doctor.

Package Labeling:

Active Ingredients

Potassium nitrate 5%.

Sodium fluoride 0.240% (0.15% w/v fluoride ion).

Inactive Ingredients

• Water, Hydrated Silica, Sorbitol, Glycerin (Vegetable), Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Retinyl Palmitate (Vitamin A), Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.

When Using This Product
  • if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
Stop Use and Ask A Dentist

if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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.


Structured Label Content

Uses
  • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • Aids in prevention of dental cavities.
Purpose

Antisensitivity

Anticavity

Directions

• Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly after meals or at least twice a day or as recommended by a dentist or doctor. Make sure to brush sensitive areas of the teeth. Minimize swallowing.

• Children under 12 years: consult a dentist or doctor.

Package Labeling:

Active Ingredients

Potassium nitrate 5%.

Sodium fluoride 0.240% (0.15% w/v fluoride ion).

Inactive Ingredients

• Water, Hydrated Silica, Sorbitol, Glycerin (Vegetable), Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Retinyl Palmitate (Vitamin A), Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.

When Using This Product (When using this product)
  • if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
Stop Use and Ask A Dentist (Stop use and ask a dentist)

if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep Out Of reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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