Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 5484999c-8e6f-430d-99a5-6893a2489467
Route
DENTAL
Published
Effective Date 2021-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.15 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Sodium Lauryl Sulfate Xanthan Gum Titanium Dioxide Polyethylene Glycol 400 Saccharin Sodium Carrageenan D&c Red No. 30 Fd&c Blue No. 1 Cocamidopropyl Betaine Sodium Citrate, Unspecified Form Zinc Chloride Sodium Tripolyphosphate Anhydrous Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-31 Until 2020-08-31

Description

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Use

aids in the prevention of dental cavities

Directions
  • adults and children 2 years and older:
    • apply toothpaste onto a toothbrush 
    • brush teeth thoroughly, preferably after each meal, or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
  • children under 2 years of age:Consult a dentist or doctor
Active Ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Other Information
  • store below 30°C (86°F)
Questions Or Comments?

Call toll-free 1-800-897-5623

Principal Display Panel

NDC 0135-0590-01

  • Aquafresh ®

fluoride toothpaste

triple protection ®

  • healthy gums*
  • strong teeth
  • fresh breath

cavity protection

Sugar Acid Protection**

from Fluoride

cool mint

NET WT 5.6 OZ (158.8 g)

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

*with twice daily brushing

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

©2015 GSK group of companies or its licensor. All rights reserved.

GSKConsumer Healthcare

Warren, NJ 07059

Made in Taiwan

1-800-897-5623

105263XA

When Using This Product,

if irritation occurs discontinue use

Inactive Ingredients (ultimate White)

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, titanium dioxide, flavor, xanthan gum, sodium hydroxide, sodium saccharin, red 30, blue 1

Inactive Ingredients (cavity Protection)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1

Inactive Ingredients (extra Fresh +whitening)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1

Inactive Ingredients (multi Action Whitening)

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium citrate, sodium saccharin, zinc chloride, red 30, blue 1

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.

Active Ingredient (cavity Protection, Extra Fresh +whitening, Multi Action Whitening)

Sodium fluoride 0.25% (0.15% w/v fluoride ion)


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Directions
  • adults and children 2 years and older:
    • apply toothpaste onto a toothbrush 
    • brush teeth thoroughly, preferably after each meal, or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
  • children under 2 years of age:Consult a dentist or doctor
Active Ingredient (Active ingredient)

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Other Information (Other information)
  • store below 30°C (86°F)
Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-897-5623

Principal Display Panel

NDC 0135-0590-01

  • Aquafresh ®

fluoride toothpaste

triple protection ®

  • healthy gums*
  • strong teeth
  • fresh breath

cavity protection

Sugar Acid Protection**

from Fluoride

cool mint

NET WT 5.6 OZ (158.8 g)

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

*with twice daily brushing

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

©2015 GSK group of companies or its licensor. All rights reserved.

GSKConsumer Healthcare

Warren, NJ 07059

Made in Taiwan

1-800-897-5623

105263XA

When Using This Product, (When using this product,)

if irritation occurs discontinue use

Inactive Ingredients (ultimate White) (Inactive ingredients (ultimate white))

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, titanium dioxide, flavor, xanthan gum, sodium hydroxide, sodium saccharin, red 30, blue 1

Inactive Ingredients (cavity Protection) (Inactive ingredients (Cavity Protection))

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1

Inactive Ingredients (extra Fresh +whitening) (Inactive ingredients (Extra Fresh +Whitening))

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1

Inactive Ingredients (multi Action Whitening) (Inactive ingredients (Multi Action Whitening))

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium citrate, sodium saccharin, zinc chloride, red 30, blue 1

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.

Active Ingredient (cavity Protection, Extra Fresh +whitening, Multi Action Whitening) (Active ingredient (Cavity Protection, Extra Fresh +Whitening, Multi Action Whitening))

Sodium fluoride 0.25% (0.15% w/v fluoride ion)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)