FDA Label for Aquafresh Kids Cavity Protection

View Indications, Usage & Precautions

Aquafresh Kids Cavity Protection Product Label

The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Sodium monofluorophosphate 0.84% (0.15% w/v fluoride ion)


Purpose



Anticavity


Use



  • •aids in the prevention of dental cavities.

When Using This Product,



if irritation occurs discontinue use.


Keep Out Of The 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.


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



  • •Do not store above 25°C (77°F)

Inactive Ingredients (Bubble Mint)



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


Questions Or Comments?



Call toll-free 1-800-897-5623


Principal Display Panel



NDC 0135-0619-01

Aquafresh®

Fluoride Toothpaste

kids

Cavity Protection

2+ years

Sugar Acid Protection **

From Fluoride

BUBBLE MINT

ADA Accepted

American Dental Association®

NET WT 4.6 OZ (130.4 g)

Aquafresh toothpaste fights cavities with fluoride...

freshens breath...

and has a great bubble mint taste, in one complete toothpaste.

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

ALWAYS FOLLOW THE LABEL

This product contains no sugar, like all ADA-accepted toothpastes.

Helps prevent cavities.

Note: If pump doesn't work, hold button down and firmly push up inside base.

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

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

©2015 GSK or its licensor

105855XB


* Please review the disclaimer below.