Drug Facts

Drug Facts
SPL v13
SPL
SPL Set ID 76adbccb-0812-4407-a6fc-a57e6f144fbb
Route
DENTAL
Published
Effective Date 2018-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Sodium Lauryl Sulfate Titanium Dioxide Xanthan Gum Saccharin Sodium Sodium Hydroxide Menthol, Unspecified Form D&c Red No. 30 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-17

Description

Potassium Nitrate (5%)* Sodium fluoride 0.24% (0.15% w/v fluoride ion) *maximum FDA sensitivity active ingredient

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity

Anticavity

Description

Potassium Nitrate (5%)* Sodium fluoride 0.24% (0.15% w/v fluoride ion) *maximum FDA sensitivity active ingredient

Uses
  • aids in the prevention of dental cavities.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Directions
  • adults and children 12 years of age and older:
    • o
      apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • o
      brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • children under 12 years of age: Consult a dentist or doctor.
Other Information
  • store below 30°C (86°F)
Active Ingredients

Potassium Nitrate (5%)*

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

*maximum FDA sensitivity active ingredient

Inactive Ingredients

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide, menthol, red 30, blue 1

Questions Or Comments?

Call toll-free 1-800-897-5623

Principal Display Panel

NDC 0135-0605-01

Aquafresh®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

triple protection®

DENTIST RECOMMENDED ACTIVE INGREDIENTS

maximum strength* sensitive

Sugar Acid Protection**

from Fluoride

  • healthy gums†
  • strong teeth
  • fresh breath

smooth mint

NET WT 5.6 OZ (158.8 g)

Aquafresh® Maximum Strength* Sensitive toothpaste cares for your mouth, helping you keep it healthy and happy. With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth.

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

targets the source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity

†with twice daily brushing

ALWAYS FOLLOW THE LABEL

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

GSK Consumer Healthcare Warren, NJ 07059

*maximum FDA sensitivity active ingredient

©2015 GSK or its licensor.

105481XA

When Using This Product,

if irritation occurs discontinue use.

Stop Use and Ask A Dentist If
  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.
Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • aids in the prevention of dental cavities.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Purpose

Antihypersensitivity

Anticavity

Directions
  • adults and children 12 years of age and older:
    • o
      apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • o
      brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • children under 12 years of age: Consult a dentist or doctor.
Other Information (Other information)
  • store below 30°C (86°F)
Active Ingredients (Active ingredients)

Potassium Nitrate (5%)*

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

*maximum FDA sensitivity active ingredient

Inactive Ingredients (Inactive ingredients)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide, menthol, red 30, blue 1

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-897-5623

Principal Display Panel

NDC 0135-0605-01

Aquafresh®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

triple protection®

DENTIST RECOMMENDED ACTIVE INGREDIENTS

maximum strength* sensitive

Sugar Acid Protection**

from Fluoride

  • healthy gums†
  • strong teeth
  • fresh breath

smooth mint

NET WT 5.6 OZ (158.8 g)

Aquafresh® Maximum Strength* Sensitive toothpaste cares for your mouth, helping you keep it healthy and happy. With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth.

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

targets the source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity

†with twice daily brushing

ALWAYS FOLLOW THE LABEL

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

GSK Consumer Healthcare Warren, NJ 07059

*maximum FDA sensitivity active ingredient

©2015 GSK or its licensor.

105481XA

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

if irritation occurs discontinue use.

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.
Keep Out of Reach of Children. (Keep out of reach of children.)

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)