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Aquafresh Big Kids

Dosage form: paste
Ingredients: SODIUM FLUORIDE 1.4mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0544

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.

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:
apply toothpaste onto a toothbrush
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.
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 30°C (86°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

Enamel Strengthening for New Adult Teeth

FRESH MINT

6+ years

Helps Protect Against Sugar Acids

NET WT 3.9 OZ (110.6g)

Aquafresh® Big Kids toothpaste is a triple-protection foaming toothpaste specially designedfor children aged6+. With active fluoride minerals for Sugar Acid Protection, it helps strengthen enamel and protect against sugar acid attack.

Child friendly FRESH MINT FLAVOR

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.

Cavity protection
Low abrasivity
Gently cleans with brushing.
Stronger enamel*
Foaming toothpaste helps protect a mix of baby and adult teeth

*as shown in laboratory tests vs regular Aquafresh® toothpaste

ALWAYS FOLLOW THE LABEL

Aquafresh and iconic nurdle device are registered trademarks of the GSK group of companies.

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Taiwan

©2014 GSK

104201XA

AQUAFRESH BIG KIDS 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:0135-0544-011 TUBE 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 Holdings (US) LLC (079944263)

Revised: 06/2016
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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