AQUAFRESH ANTI-CAVITY- sodium monofluorophosphate paste 
AQUAFRESH CAVITY PROTECTION- sodium monofluorophosphate paste 
AQUAFRESH EXTRA FRESH WHITENING- sodium monofluorophosphate paste 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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 reach of children under 6 years of age.

If you accidentally swallow more than used for brushing, get medical help or contact the 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 until good habits are established.
•
children under 2 years consult a dentist or doctor

Other information

•
store below 30°C (86°F)

Inactive ingredients (Anti-Cavity)

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

Inactive ingredient (cavity protection)

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

Inactive ingredients (cavity protection)

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

Inactive ingredients (extra fresh WHITENING)

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

Questions or comments?

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

Principal Display Panel

NDC 0135-0219-08

Aquafresh®
FLUORIDE TOOTHPASTE

TRIPLE PROTECTION®

ANTI-CAVITY

NET WT 3.5 oz (99.2g)

ADA Accepted American Dental Association®

Clinically proven to fight cavities

for a smooth, clean feeling

And a fresh sensation that lasts

Aquafresh Anti-Cavity fights cavities and strengthens teeth with fluoride...

leaves your teeth feeling smooth and clean...

and gives your whole mouth a fresh, clean sensation that lasts.

www.aquafresh.com

"The ADA Council of Scientific Affairs' Acceptance of Aquafresh Anti-Cavity 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®, and various design elements are trademarks of the GlaxoSmithKline group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in England

©2009 GlaxoSmithKline

30672XB

Aquafresh Anti-Cavity carton

Principal Display Panel

NDC 0135-0129-03

Aquafresh®

fluoride toothpaste

triple protection®

cavity protection

cool mint

NET WT 6.4 oz (181.4g)

DENTIST RECOMMENDED ACTIVE INGREDIENT

NEW LOOK

healthy gums

strong teeth

fresh breath

with regular brushing

Aquafresh® Triple Protection® toothpaste cares for your mouth, helping you keep it healthy and happy. While you brush, our Triple Protection® formulation strengthens your teeth, helps protect them from cavities and leaves them feeling clean.

For lots of reasons to smile visit www.Aquafresh.com

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PORTECTION, 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 the England

©2013 GlaxoSmithKline

103261XA

Aquafresh cavity protection 6.4oz (181.4g) carton

Principal Display Panel

NDC 0135-0130-03

Aquafresh®

FLUORIDE TOOTHPASTE

TRIPLE PROTECTION®

cavity protection

cool mint

NEW LOOK

NET WT 6.4 oz (181.4g)

healthy gums

strong teeth

fresh breath

with regular brushing

ALWAYS FOLLOW THE LABEL

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

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies.

www.Aquafresh.com

Distributed by

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in England

©2013 GlaxoSmithKline

103349XA

Aquafresh Cavity Protection Pump 6.4oz (181.4g) label

Principal Display Panel

NDC 0135-0531-02

Aquafresh®

fluoride toothpaste

triple protection®

extra fresh® + whitening

fresh mint

NET WT 6.4 oz (181.4g)

DENTIST RECOMMENDED ACTIVE INGREDIENT

NEW LOOK

healthy gums

strong teeth

fresh breath

with regular brushing

Aquafresh® Triple Protection® toothpaste cares for your mouth helping you to keep it healthy and happy. While you brush, our Extra Fresh® toothpaste gently whitens your teeth, leaving you with a feeling of freshness.

For lots of reasons to smile visit www.Aquafresh.com

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PORTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2013 GlaxoSmithKline

103300XA

Aquafresh extra fresh plus whitening 6.4oz (181.4g) carton
AQUAFRESH  ANTI-CAVITY
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0219
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0219-081 in 1 CARTON01/28/201111/30/2012
199.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/28/201111/30/2012
AQUAFRESH  CAVITY PROTECTION
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0129
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0129-031 in 1 CARTON01/28/201106/30/2016
1181.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0129-041 in 1 CARTON01/28/201104/30/2016
2232.4 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0135-0129-081 in 1 CARTON01/28/201104/30/2016
399.2 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:0135-0129-094 in 1 CARTON01/28/201108/31/2016
4232.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/28/201108/31/2016
AQUAFRESH  CAVITY PROTECTION
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0130
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0130-031 in 1 CARTON01/28/201105/31/2016
1181.4 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/28/201105/31/2016
AQUAFRESH  EXTRA FRESH WHITENING
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0531
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0531-011 in 1 CARTON02/16/201202/29/2016
199.2 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0531-021 in 1 CARTON02/16/201209/30/2015
2181.4 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0135-0531-031 in 1 CARTON02/16/201203/31/2016
3232.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/16/201203/31/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2017
Document Id: bf3c5ad9-cd03-4ee0-a195-807d1c50ce73
Set id: 57647d04-1e5a-440d-9c11-a955b50b9c3a
Version: 12
Effective Time: 20170102
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC