AQUAFRESH BIG KIDS- sodium fluoride paste 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Sodium fluoride (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

When using this product,

if irritation occurs discontinue use

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.

Directions

•
adults and children 2 years of age and older:
o
appl toothpaste onto a toothbrush
o
brush teeth thoroughly, preferably after each meal, 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.
o
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 25°C (77°F)

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium methyl cocoyl taurate, flavor, carrageenan, sodium saccharin, polyethylene, red 30, blue 1 lake

Questions or comments?

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

Principal Display Panel

NDC 0135-0544-01

Aquafresh®

Fluoride Toothpaste

Big

kids

Cavity Protection

new formulation

Enamel Strengthening for New Adult Teeth

FRESH MINT

6+ years

Bubble action seeks out hard to reach areas

NET WT 3.9 OZ (110.5g)

New adult teeth are not as strong as you think. Enamel on new adult teeth is softer and more vulnerable to decay and the mix of baby and adult teeth makes them more difficult to clean.

Child friendly FRESH MINT FLAVOR

Aquafresh® Big Kids toothpaste is a foaming toothpaste specially designed for children aged 6+. It helps strengthen and protect enamel from decay caused by plaque acid.

Gently cleans with brushing.

Fluoride protection

Stronger enamel*

Foaming toothpaste helps protect a mix of baby and adult teeth

Cavity protection

Low abrasivity

*as shown in laboratory tests vs regular Aquafresh® toothpaste

ALWAYS FOLLOW THE LABEL

Aquafresh, the iconic nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies.

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Taiwan

©2013 GlaxoSmithKline

102446XA

Aquafresh Big Kids 3.9oz (110.5 g) carton
AQUAFRESH BIG KIDS 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0544
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
XANTHAN GUM 
TITANIUM DIOXIDE 
COCAMIDOPROPYL BETAINE 
SODIUM METHYL COCOYL TAURATE 
CARRAGEENAN 
SACCHARIN SODIUM 
POLYETHYLENE GLYCOLS 
D&C RED NO. 30 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (fresh mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0544-011 in 1 CARTON
1110.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/07/2014
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 1/2014
Document Id: ffd10d32-44eb-4788-b1ce-30b37a857452
Set id: ffd10d32-44eb-4788-b1ce-30b37a857452
Version: 1
Effective Time: 20140108
 
GlaxoSmithKline Consumer Healthcare LP