AQUAFRESH BUBBLE FRESH - sodium monofluorophosphate paste
AQUAFRESH - sodium monofluorophosphate paste
GlaxoSmithKline Consumer Healthcare LP

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Drug Facts

Active ingredient

Sodium monofluorophosphate (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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 soft bristle toothbrush
- brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician
- to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established
children under 2 years ask a dentist or physician

Other information

store below 25°C (77°F)

Inactive ingredients (bubble fresh)

sorbitol, calcium carbonate, water, hydrated silica, glycerin, PEG-8, flavor, sodium lauryl sulfate, cellulose gum, titanium dioxide, sodium bicarbonate, sodium saccharin, calcium carrageenan, sodium benzoate, D&C red #30

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, calcium carrageenan, sodium benzoate, FD&C blue #1 lake, D&C red #30 lake

Questions or comments?

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

Principal Display Panel

Aquafresh kids

FLUORIDE TOOTHPASTE

TRIPLE PROTECTION

bubble fresh

NET WT. 4.6 oz (130.4g)

ADA Accepted American Dental Association®

Aquafresh fights cavities with fluoride...

freshens breath...

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

www.Aquafresh.com

Aqua®, Aquafresh®, Triple Protection®, and various design elements are trademarks of the GlaxoSmithKline group of companies.

This product contains no sugar.

"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."

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in England

From the Aqua® family of products.

30050XC

Aquafresh Kids Bubble Fresh carton

Principal Display Panel

Aquafresh kids

FLUORIDE TOOTHPASTE

TRIPLE PROTECTION

bubble mint

NET WT. 4.6 oz (130.4g)

ADA Accepted American Dental Association®

Aquafresh fights cavities with fluoride...

freshens breath...

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

"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."

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

Aqua®, Aquafresh®, Triple Protection®, the Red, White, and Aqua-blue design, and various other design and package elements are trademarks of the GlaxoSmithKline group of companies.

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

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in England

100023XA

Aquafresh Kids Bubble Mint carton

AQUAFRESH BUBBLE FRESH
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0135-0442
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION)	FLUORIDE ION	1.10 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL
CALCIUM CARBONATE
WATER
HYDRATED SILICA
GLYCERIN
POLYETHYLENE GLYCOL 400
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
TITANIUM DIOXIDE
SODIUM BICARBONATE
SACCHARIN SODIUM
CARRAGEENAN
SODIUM BENZOATE
D&C RED NO. 30

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0135-0442-01	1 TUBE In 1 CARTON	contains a TUBE
1		130.4 g In 1 TUBE	This package is contained within the CARTON (0135-0442-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/28/2011

AQUAFRESH
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0135-0126
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION)	FLUORIDE ION	1.10 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL
WATER
CALCIUM CARBONATE
HYDRATED SILICA
GLYCERIN
POLYETHYLENE GLYCOL 400
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
TITANIUM DIOXIDE
SODIUM BICARBONATE
SACCHARIN SODIUM
CARRAGEENAN
SODIUM BENZOATE
FD&C BLUE NO. 1
D&C RED NO. 30

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0135-0126-02	130.4 g In 1 CAN	None
2	0135-0126-04	1 TUBE In 1 CARTON	contains a TUBE
2		119 g In 1 TUBE	This package is contained within the CARTON (0135-0126-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/28/2011

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 01/2011GlaxoSmithKline Consumer Healthcare LP