Drug Facts

Drug Facts
SPL v23
SPL
SPL Set ID aaff19d9-4ba5-462a-893b-7220feb25d6c
Route
DENTAL
Published
Effective Date 2024-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.13 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Polyethylene Glycol 400 Sodium Lauryl Sulfate Xanthan Gum Titanium Dioxide Cocamidopropyl Betaine Saccharin Sodium D&c Red No. 30

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-03-25 Until 2019-07-31

Description

Sodium fluoride (0.15% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride (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 yearsconsult a dentist or doctor
Active Ingredient

Sodium fluoride (0.15% w/v fluoride ion)

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

call toll-free 1-800-897-5623(English/Spanish) weekdays

Principal Display Panel

NDC 0135-0234-08

Aquafresh ®

fluoride toothpaste

triple protection ®

EXTREME CLEAN ®

WITH MICRO-ACTIVE FOAMING ACTION

whitening action

Sugar Acid Protection**

from Fluoride

mint blast

helps restore natural whiteness

TWIN VALUE PACK

2 TUBES OF 5.6 OZ (158.7g) EACH

TOTAL NET WT 11.2 OZ (317.4g)

Aquafresh ®Extreme Clean ®Whitening Action toothpaste creates micro-active foam which seeks out hard to reach places in your mouth and fights bad breath. It rinses clear and carefully polishes your teeth so after only one tube you’ll be left with significantly cleaner, smoother, whiter teeth*. Take the Feeling of Clean to the Extreme! ®

Sugar Acid Protection**

**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

*vs a regular toothpaste

ALWAYS FOLLOW THE LABEL

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

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GSKConsumer Healthcare

Warren, NJ 07059

©2015 GSK group of companies

1-800-897-5623

105517XA

When Using This Product,

if irritation occurs discontinue use

Inactive Ingredients (deep Action)

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, iron oxide, red 30

Inactive Ingredients (whitening Action)

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, sodium lauryl sulfate, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, synthetic iron oxide, red 30

Keep Out of Reach of Children Under 6 Years of Age.

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Keep Out of Reach of Children Under 6 Years of Age. (whitening Multi Action Only)

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 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 yearsconsult a dentist or doctor
Active Ingredient (Active ingredient)

Sodium fluoride (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(English/Spanish) weekdays

Principal Display Panel

NDC 0135-0234-08

Aquafresh ®

fluoride toothpaste

triple protection ®

EXTREME CLEAN ®

WITH MICRO-ACTIVE FOAMING ACTION

whitening action

Sugar Acid Protection**

from Fluoride

mint blast

helps restore natural whiteness

TWIN VALUE PACK

2 TUBES OF 5.6 OZ (158.7g) EACH

TOTAL NET WT 11.2 OZ (317.4g)

Aquafresh ®Extreme Clean ®Whitening Action toothpaste creates micro-active foam which seeks out hard to reach places in your mouth and fights bad breath. It rinses clear and carefully polishes your teeth so after only one tube you’ll be left with significantly cleaner, smoother, whiter teeth*. Take the Feeling of Clean to the Extreme! ®

Sugar Acid Protection**

**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

*vs a regular toothpaste

ALWAYS FOLLOW THE LABEL

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

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GSKConsumer Healthcare

Warren, NJ 07059

©2015 GSK group of companies

1-800-897-5623

105517XA

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

if irritation occurs discontinue use

Inactive Ingredients (deep Action) (Inactive ingredients (deep action))

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, iron oxide, red 30

Inactive Ingredients (whitening Action) (Inactive ingredients (whitening action))

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, sodium lauryl sulfate, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, synthetic iron oxide, red 30

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Keep Out of Reach of Children Under 6 Years of Age. (whitening Multi Action Only) (Keep out of reach of children under 6 years of age. (Whitening Multi Action only))

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

All Sections (JSON)