Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 462eb309-deca-4464-b13a-7ae314e53ede
Route
DENTAL
Published
Effective Date 2024-01-24
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 Polyethylene Glycol 400 Sodium Lauryl Sulfate Xanthan Gum Titanium Dioxide Cocamidopropyl Betaine Sodium Citrate, Unspecified Form Saccharin Sodium Zinc Chloride Ferric Oxide Yellow D&c Red No. 30 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-01

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 of age 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 0.25% (0.15% w/v fluoride ion)

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

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

Questions Or Comments?

Call toll-free 1-800-897-5623

Principal Display Panel

NDC 0135-0604-01

Aquafresh ®

triple protection®

fluoride toothpaste

pure breath action

Sugar Acid Protection**

from Fluoride

EXTREME CLEAN ®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

for 80% cleaner, purer breath*

NET WT 5.6 OZ (158.8g )

fresh mint

Aquafresh ®Extreme Clean ®Pure Breath Action toothpaste creates micro-active foam which seeks out hard to reach places and rinses clear to leave your teeth clean and smooth. It neutralizes bad breath odors for 80% cleaner, purer breath.* Take the Feeling of Clean to the Extreme! ®

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

triple protection ®

  • healthy gums†
  • strong teeth
  • fresh breath

†with twice daily brushing

*immediately after brushing versus a zinc free toothpaste

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

1-800-897-5623

105483XA

When Using This Product,

if irritation occurs discontinue use.

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.
Purpose

Anticavity

Directions
  • adults and children 2 years of age 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 0.25% (0.15% w/v fluoride ion)

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

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

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-897-5623

Principal Display Panel

NDC 0135-0604-01

Aquafresh ®

triple protection®

fluoride toothpaste

pure breath action

Sugar Acid Protection**

from Fluoride

EXTREME CLEAN ®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

for 80% cleaner, purer breath*

NET WT 5.6 OZ (158.8g )

fresh mint

Aquafresh ®Extreme Clean ®Pure Breath Action toothpaste creates micro-active foam which seeks out hard to reach places and rinses clear to leave your teeth clean and smooth. It neutralizes bad breath odors for 80% cleaner, purer breath.* Take the Feeling of Clean to the Extreme! ®

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

triple protection ®

  • healthy gums†
  • strong teeth
  • fresh breath

†with twice daily brushing

*immediately after brushing versus a zinc free toothpaste

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

1-800-897-5623

105483XA

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

if irritation occurs discontinue use.

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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