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Aquafresh

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 1.10mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0126

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 monofluorophosphate (0.15% 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 the 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 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 (bubble mint)
store below 25°C (77°F)

Other information (fresh ‘n fruity)
store below 30°C (86°F)

Inactive ingredients (bubble mint)

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

Inactive ingredients (fresh ‘n fruity)

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

Questions or comments?

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

Principal Display Panel

NDC 0135-0126-02

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 (130.4g)

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.

Aquafresh and the iconic Nurdle device are registered trademarks owned by or licensed to the GSK group of companies.

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

"The ADA Council on Scientific Affairs' Acceptance of Aquafresh Kids is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed."

Distributed by

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK group of companies or its licensor. All rights reserved

100023XE

Principal Display Panel

NDC 0135-0534-08

Aquafresh®

Fluoride Toothpaste

CAVITY PROTECTION

kids

fresh ‘n fruity

2+ YEARS

NET WT. 4.6 oz (130.4g)

Aquafresh® toothpaste fights cavities with fluoride…

freshens breath…

and has a great fresh and fruity flavor, in one complete toothpaste

ALWAYS FOLLOW THE LABEL

www.Aquafresh.com

AQUAFRESH and the iconic Nurdle device are registered trademarks of the GSK group of companies.

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2014 GSK

104471XA

AQUAFRESH 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0126
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
CALCIUM CARBONATE 
HYDRATED SILICA 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
TITANIUM DIOXIDE 
SODIUM BICARBONATE 
SACCHARIN SODIUM 
CARRAGEENAN 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0126-02130.4 g in 1 CAN
2NDC:0135-0126-041 TUBE in 1 CARTON
2119 g in 1 TUBE
3NDC:0135-0126-081 TUBE in 1 CARTON
322.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/28/2011
AQUAFRESH  FRESH N FRUITY
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0534
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
CALCIUM CARBONATE 
HYDRATED SILICA 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
TITANIUM DIOXIDE 
SODIUM BICARBONATE 
SACCHARIN SODIUM 
CARRAGEENAN 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0534-081 TUBE in 1 CARTON
1130.4 g in 1 TUBE
2NDC:0135-0534-071 TUBE in 1 CARTON
222.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/09/2012
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIOperations
Ultradent Products, Inc.013369913MANUFACTURE(0135-0126), ANALYSIS(0135-0126), PACK(0135-0126), LABEL(0135-0126)

Revised: 12/2016
 
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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