Peach Iced Tea Flavor Sodium Fluoride Anticavity Toothpaste

Peach Iced Tea Flavor Sodium Fluoride Anticavity Toothpaste
SPL v3
SPL
SPL Set ID 0eba92d1-cbdc-9c96-e063-6294a90a9afc
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
Carboxymethylcellulose Sodium, Unspecified Form Sodium Gluconate Pentylene Glycol Methyl Diisopropyl Propionamide Benzoic Acid Sodium Phosphate, Dibasic, Anhydrous Sorbitol Sodium Lauroyl Sarcosinate Glycerin Benzyl Alcohol Sucralose Menthol Zinc Lactate Caprylyl Glycol Water Calcium Glycerophosphate Xanthan Gum Hydrated Silica Xylitol Potassium Pyrophosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-12

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

Peach Iced Tea 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.

Section 51945-4

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

Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Calcium Glycerophosphate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Caprylyl Glycol, Sucralose, Menthol, Sodium Gluconate, Pentylene Glycol, Zinc Lactate, Methyl Diisopropyl Propionamide, Benzoic Acid

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)

Peach Iced Tea 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.

Section 51945-4 (51945-4)

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)

Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Calcium Glycerophosphate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Caprylyl Glycol, Sucralose, Menthol, Sodium Gluconate, Pentylene Glycol, Zinc Lactate, Methyl Diisopropyl Propionamide, Benzoic Acid

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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