Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpaste

Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpaste
SPL v4
SPL
SPL Set ID 0ef6f8b5-8565-b364-e063-6294a90aabbc
Route
DENTAL
Published
Effective Date 2024-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.4 mg)
Inactive Ingredients
Sorbitol Sodium Phosphate, Dibasic, Anhydrous Sodium Lauroyl Sarcosinate Carboxymethylcellulose Sodium, Unspecified Form Sucralose Methyl Diisopropyl Propionamide Water Xanthan Gum Xylitol Fd&c Blue No. 1 Hydrated Silica Glycerin Pentylene Glycol Benzyl Alcohol Caprylyl Glycol Sodium Gluconate Potassium Pyrophosphate Zinc Lactate Benzoic Acid Fd&c Red No. 40

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

Grape Bubblegum 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.

Directions
  • adults and children 2 years of age 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 neceaasry 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)

Inactive Ingredients

Aqua, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Caprylyl Glycol, Sucralose, Sodium Gluconate, Pentylene Glycol, Methyl Diisopropyl Propionamide, Zinc Lactate, Benzoic Acid, FD&C Red No. 40, FD&C Blue No. 1

When Using This Product
  • do not swallow
  • do not use in eye area
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)

Grape Bubblegum 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.

Purpose

Anticavity

Directions
  • adults and children 2 years of age 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 neceaasry 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)

Inactive Ingredients (Inactive ingredients)

Aqua, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Caprylyl Glycol, Sucralose, Sodium Gluconate, Pentylene Glycol, Methyl Diisopropyl Propionamide, Zinc Lactate, Benzoic Acid, FD&C Red No. 40, FD&C Blue No. 1

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)

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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