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

Purpose

Anticavity

Description

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


Medication Information

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
Other Information
  • store below 30°C (86°F)
Description

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

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

Use

aids in the prevention of dental cavities

Active Ingredient

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

Questions Or Comments?

Call toll-free 1-800-897-5623

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

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
Other Information (Other information)
  • store below 30°C (86°F)
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

Use

aids in the prevention of dental cavities

Active Ingredient (Active ingredient)

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

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-897-5623

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

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