Strawberry Flavor Sodium Fluoride Anticavity Toothpaste

Strawberry Flavor Sodium Fluoride Anticavity Toothpaste
SPL v5
SPL
SPL Set ID 0ef766ae-754a-f185-e063-6294a90a3299
Route
DENTAL
Published
Effective Date 2024-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.4 mg)
Inactive Ingredients
D&c Red No. 33 Water Sodium Lauroyl Sarcosinate Hydrated Silica Glycerin Carboxymethylcellulose Sodium, Unspecified Form Caprylyl Glycol Pentylene Glycol Methyl Diisopropyl Propionamide Sodium Phosphate, Dibasic, Anhydrous Sorbitol Zinc Lactate Xanthan Gum Benzyl Alcohol Benzoic Acid Sucralose Xylitol Potassium Pyrophosphate Sodium Gluconate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-15

Description

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Use

aids in the prevention of dental cavities

Label

Warinings

Warnings

Directions
  • adults and children 2 years of ange and older:Brush teeth thoroughly preferably after each meal or at least twice a day, or use as directed by a dentist or doctor.
  • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • supervise children as necessary until capable of using without supervision.
  • children under 2 years of age: Consult a dentist or doctor.
Active Ingredient

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Other Information

Strawberry Flavor Sodium Fluoride Anticavity Toothpaste

Manufactured for:

Hismile Pty Ltd, 225 Burleigh

Connection Rd, Burleigh Waters,

Queensland, Australia 4220.

Formulated in Australia.

Made in USA.

www.hismileteeth.com

© Hismile Pty Ltd, 2022

TRUSTED BY DENTISTS

sugar-free

cruelty- free

no SLS & PEGs

vegan

Hismile uses the highest quality ingredients to provide a superior clean with oral health benefits. Paired with a refreshing burst of flavor, this toothpaste creates a unique smile care experience.

Inactive Ingredients

Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Disodium Phosphate, Flavor, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Caprylyl Glycol, Pentylene Glycol, Benzyl Alcohol, Sucralose, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Benzoic Acid, D&C Red No. 33

When Using This Product
  • do not swallow
  • do not use in eye area
Keep Out of Reach of Children Under 6 Years of Age

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

aids in the prevention of dental cavities

Label (label)

Purpose

Anticavity

Warinings

Warnings

Directions
  • adults and children 2 years of ange and older:Brush teeth thoroughly preferably after each meal or at least twice a day, or use as directed by a dentist or doctor.
  • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • supervise children as necessary until capable of using without supervision.
  • children under 2 years of age: Consult a dentist or doctor.
Active Ingredient (Active ingredient)

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Other Information (Other information)

Strawberry Flavor Sodium Fluoride Anticavity Toothpaste

Manufactured for:

Hismile Pty Ltd, 225 Burleigh

Connection Rd, Burleigh Waters,

Queensland, Australia 4220.

Formulated in Australia.

Made in USA.

www.hismileteeth.com

© Hismile Pty Ltd, 2022

TRUSTED BY DENTISTS

sugar-free

cruelty- free

no SLS & PEGs

vegan

Hismile uses the highest quality ingredients to provide a superior clean with oral health benefits. Paired with a refreshing burst of flavor, this toothpaste creates a unique smile care experience.

Inactive Ingredients (Inactive ingredients)

Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Disodium Phosphate, Flavor, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Caprylyl Glycol, Pentylene Glycol, Benzyl Alcohol, Sucralose, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Benzoic Acid, D&C Red No. 33

When Using This Product (When using this product)
  • do not swallow
  • do not use in eye area
Keep Out of Reach of Children Under 6 Years of Age (Keep out of reach of children under 6 years of age)

Keep out of reach of children under 6 years of age. 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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