AQUAFRESH description, usages, side effects, indications, overdosage, supplying and lots more!

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AQUAFRESH

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Potassium nitrate (5%)

Sodium fluoride (0.15 w/v fluoride ion)

Antihypersensitivity

Anticavity

  • •builds increasing protection against painful sensitivity of the teeth due to cold, heat, acids, sweets, or contact
  • •aids in the prevention of dental cavities

Stop use and ask a dentist if:

  • •the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • •pain/sensitivity still persists after 4 weeks of use

Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • adults and children 12 years of age and older:
    • ∘ apply at least a 1-inch strip of the product onto a soft bristle toothbrush
    • ∘brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and no more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • children under 12 years of age: consult a dentist or doctor
  • •store below 30°C (86°F)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium hydroxide, sodium saccharin, sodium benzoate, blue 1 lake, red 30 lake

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

Principal Display Panel

NDC 0135-0132-03

Aquafresh®

fluoride toothpaste for sensitive teeth

triple protection®

maximum strength*

sensitive

  • •healthly gums†
  • •strong teeth
  • •fresh breath

smooth mint

NET WT 5.6 OZ (158.7g)

DENTIST RECOMMENDED ACTIVE INGREDIENTS

Aquafresh® Triple Protection® toothpaste cares for your mouth, helping you keep it healthy and happy.

With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth.

targets source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity

†with twice daily brushing

For lots of reasons to smile

visit www.Aquafresh.com

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2014 GlaxoSmithKline

ALWAYS FOLLOW THE LABEL

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

*maximum FDA sensitivity active ingredient

103265XB

AQUAFRESH

potassium nitrate and sodium fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0132
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE NITRATE ION 50 mg
SODIUM FLUORIDE FLUORIDE ION 1.5 mg

Inactive Ingredients

Ingredient Name Strength
water
HYDRATED SILICA
sorbitol
GLYCERIN
SODIUM LAURYL SULFATE
titanium dioxide
XANTHAN GUM
SODIUM HYDROXIDE
saccharin sodium
SODIUM BENZOATE
FD&C BLUE NO. 1
ALUMINUM OXIDE
D&C RED NO. 30

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 158.7 in 1 TUBE
2 198.5 in 1 TUBE
3 NDC:0135-0132-07 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-03-29


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