AQUAFRESH EXTREME CLEAN WHITENING ACTION- sodium fluoride paste AQUAFRESH EXTREME CLEAN DEEP ACTION- sodium fluoride paste

AQUAFRESH by

Drug Labeling and Warnings

AQUAFRESH by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium fluoride (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 a Poison Control Center right away.

Keep out of reach of children under 6 years of age. (Whitening Multi Action only)

If more than used for brushing is accidentally swallowed, 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, or 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 consult a dentist or doctor

Other information

• store below 30°C (86°F)

Inactive ingredients (whitening action)

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, sodium lauryl sulfate, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, synthetic iron oxide, red 30

Inactive ingredients (deep action)

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, iron oxide, red 30

Questions or comments?

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

Principal Display Panel

NDC: 0135-0234-08

Aquafresh®

fluoride toothpaste

triple protection ®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION

whitening action

Sugar Acid Protection**

from Fluoride

mint blast

helps restore natural whiteness

TWIN VALUE PACK

2 TUBES OF 5.6 OZ (158.7g) EACH

TOTAL NET WT 11.2 OZ (317.4g)

Aquafresh® Extreme Clean® Whitening Action toothpaste creates micro-active foam which seeks out hard to reach places in your mouth and fights bad breath. It rinses clear and carefully polishes your teeth so after only one tube you’ll be left with significantly cleaner, smoother, whiter teeth*. Take the Feeling of Clean to the Extreme!®

Sugar Acid Protection**

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

triple protection

• healthy gums†
• strong teeth
• fresh breath

†with twice daily brushing

*vs a regular toothpaste

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GSK Consumer Healthcare

Warren, NJ 07059

©2015 GSK group of companies

1-800-897-5623

105517XA

Principal Display Panel

NDC: 0135-0432-02

Aquafresh®

fluoride toothpaste

triple protection®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

deep action

Sugar Acid Protection**

from Fluoride

mint zest

for a whole mouth clean

NET WT 5.6 oz (158.7g)

Aquafresh® Extreme Clean® Deep Action toothpaste creates micro-active foam which seeks hard to reach places; in between teeth and even the back of your tongue and rinses clear to leave your teeth clean and smooth. Enjoy a whole mouth clean. Take the Feeling of Clean to the Extreme!®

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

healthy gums*

strong teeth

fresh breath

*with twice daily brushing

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK group of companies

We value your feedback

1-800-897-5623

101883XD

INGREDIENTS AND APPEARANCE

AQUAFRESH  EXTREME CLEAN WHITENING ACTION
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0234
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.13 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0234-06	1 in 1 CARTON	03/25/2011
1		158.7 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0234-08	2 in 1 CARTON	03/25/2011
2		158.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/25/2011

AQUAFRESH  EXTREME CLEAN DEEP ACTION
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0432
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.13 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0432-02	1 in 1 CARTON	03/25/2011	07/31/2019
1		158.7 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0432-05	1 in 1 CARTON	03/25/2011	07/31/2019
2		22.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/25/2011	07/31/2019

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)