AQUAFRESH BUBBLE FRESH- sodium monofluorophosphate paste 
AQUAFRESH- sodium monofluorophosphate paste 
AQUAFRESH FRESH N FRUITY- sodium monofluorophosphate 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 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

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 0135-0442-01

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."

©2009 GlaxoSmithKline

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

NDC 0135-0126-02

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

©2010 GlaxoSmithKline

100023XA

Aquafresh Kids Bubble Mint carton

Principal Display Panel

NDC 0135-0534-08

Aquafresh® Kids

FLUORIDE TOOTHPASTE

TRIPLE PROTECTION

fresh ‘n fruity

CAVITY PROTECTION

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

www.Aquafresh.com

AQUAFRESH, TRIPLE PROTECTION, 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 England

©2011 GlaxoSmithKline

100999XA

Aquafresh Kids fresh n fruity 4.6 oz (130.4 g) carton
AQUAFRESH  BUBBLE FRESH
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0442
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 
CALCIUM CARBONATE 
WATER 
HYDRATED SILICA 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
TITANIUM DIOXIDE 
SODIUM BICARBONATE 
SACCHARIN SODIUM DIHYDRATE 
CARRAGEENAN 
SODIUM BENZOATE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0442-011 in 1 CARTON
1130.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/28/2011
AQUAFRESH 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
TITANIUM DIOXIDE 
SODIUM BICARBONATE 
SACCHARIN SODIUM DIHYDRATE 
CARRAGEENAN 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0126-02130.4 g in 1 CAN
2NDC:0135-0126-041 in 1 CARTON
2119 g in 1 TUBE
3NDC:0135-0126-081 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 DRUG LABELItem 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 
TITANIUM DIOXIDE 
SODIUM BICARBONATE 
SACCHARIN SODIUM DIHYDRATE 
CARRAGEENAN 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0534-081 in 1 CARTON
1130.4 g in 1 TUBE
2NDC:0135-0534-071 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 LP (828924212)
Establishment
NameAddressID/FEIBusiness Operations
Ultradent Products, Inc.013369916MANUFACTURE(0135-0126), ANALYSIS(0135-0126), PACK(0135-0126), LABEL(0135-0126)

Revised: 11/2012
 
GlaxoSmithKline Consumer Healthcare LP