FDA Label for Aquafresh Sensitive Maximum Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (0135-0132)
- ACTIVE INGREDIENT (0135-0605)
- PURPOSE
- USE (0135-0132)
- USE (0135-0605)
- WHEN USING THIS PRODUCT,
- STOP USE AND ASK A DENTIST IF: (0135-0132)
- STOP USE AND ASK A DENTIST IF (0135-0605)
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS (0135-0132)
- DIRECTIONS (0135-0605)
- OTHER INFORMATION
- INACTIVE INGREDIENTS (0135-0132)
- INACTIVE INGREDIENTS (0135-0605)
- QUESTIONS OR COMMENTS? (0135-0132)
- QUESTIONS OR COMMENTS? (0135-0605)
- PRINCIPAL DISPLAY PANEL
Aquafresh Sensitive Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (0135-0132)
Potassium nitrate (5%)
Sodium fluoride (0.15 w/v fluoride ion)
Active Ingredient (0135-0605)
Potassium nitrate (5%)
Sodium fluoride 0.24% (0.15 w/v fluoride ion)
Purpose
Antihypersensitivity
Anticavity
Use (0135-0132)
• builds increasing protection against painful sensitivity of the teeth due to cold, heat, acids, sweets, or contact• aids in the prevention of dental cavities
Use (0135-0605)
• aids in the prevention of dental cavities.• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
When Using This Product,
if irritation occurs discontinue use.
Stop Use And Ask A Dentist If: (0135-0132)
• 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
Stop Use And Ask A Dentist If (0135-0605)
• 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.
Directions (0135-0132)
• 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
Directions (0135-0605)
• 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 not 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.
Other Information
• store below 30°C (86°F)
Inactive Ingredients (0135-0132)
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
Inactive Ingredients (0135-0605)
water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide, menthol, red 30, blue 1
Questions Or Comments? (0135-0132)
call toll-free 1-800-897-5623 (English/Spanish) weekdays
Questions Or Comments? (0135-0605)
Call toll-free 1-800-897-5623
Principal Display Panel
NDC 0135-0132-03
Aquafresh®
fluoride toothpaste for sensitive teeth
triple protection®
DENTIST RECOMMENDED ACTIVE INGREDIENTS
maximum strength*
sensitive
Sugar Acid Protection**
• healthy gums†• strong teeth• fresh breath• healthy gums†• strong teeth• fresh breath
From Fluoride
smooth mint
NET WT 5.6 OZ (158.7g)
Aquafresh® Maximum Strength*Sensitive 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.
**With Sugar Acid
targets source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity
†with twice daily brushing
GlaxoSmithKline Consumer Healthcare, L.P.
Moon Township, PA 15108
©2015 GSK
ALWAYS FOLLOW THE LABEL
AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.
*maximum FDA sensitivity active ingredient
103265XC
NDC 0135-0605-01
Aquafresh®
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
triple protection®
DENTIST RECOMMENDED ACTIVE INGREDIENTS
maximum strength* sensitive
Sugar Acid Protection**
from Fluoride
smooth mint
NET WT 5.6 OZ (158.8g)
Aquafresh® Maximum Strength* Sensitive 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.
**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.
targets the source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity
†with twice daily brushing
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or licensed of the GSK group of companies.
GSK Consumer Healthcare Warren, NJ 07059
*maximum FDA sensitivity active ingredient
©2015 GSK or its licensor.
105481XA
* Please review the disclaimer below.