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  5. Label Information: Sensodyne Pronamel Fresh Breath

FDA Label for Sensodyne Pronamel Fresh Breath

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WHEN USING THIS PRODUCT,
    5. STOP USE AND ASK A DENTIST IF
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION (GENTLE WHITENING, DAILY PROTECTION, FRESH BREATH)
    9. OTHER INFORMATION (MULTI-ACTION)
    10. INACTIVE INGREDIENTS (GENTLE WHITENING)
    11. INACTIVE INGREDIENTS (DAILY PROTECTION)
    12. INACTIVE INGREDIENTS (FRESH BREATH)
    13. INACTIVE INGREDIENTS (MULTI-ACTION)
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Sensodyne Pronamel Fresh Breath 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 Ingredients



Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion


Purpose



Antihypersensitivity

Anticavity


Uses



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

When Using This Product,



if irritation occurs discontinue use.


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.


Directions



  • •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 (Gentle Whitening, Daily Protection, Fresh Breath)



store below 30°C (86°F)


Other Information (Multi-Action)



Store below 25°C (77°F)


Inactive Ingredients (Gentle Whitening)



water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide


Inactive Ingredients (Daily Protection)



water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide


Inactive Ingredients (Fresh Breath)



water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide


Inactive Ingredients (Multi-Action)



water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, mica, titanium dioxide, sodium hydroxide


Questions Or Comments?



call toll-free 1-866-844-2797


Principal Display Panel



NDC 0135-0484-01

SENSODYNE®

PRONAMEL®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

GENTLE WHITENING

STRENGTHENS AND RE-HARDENS ENAMEL

PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

ALPINE BREEZE®

NET WT 4.0 OZ (113g)

WINE ACIDS

FRUIT ACIDS

SODA ACIDS

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

#1 Dentist Recommended Brand for Strengthening & Protecting Enamel†

MULTI-ACTION

ACID PROTECTION FORMULA

Brushing twice a day with ProNamel helps to:

  • •Protect enamel against the effects of acid erosion
  • •Restore natural whiteness
  • •Clean effectively and freshen breath
  • •Provide cavity protection
  • •Maintain healthy teeth and gums

    • Pronamel is also suitable for people with sensitive teeth.

    Help protect your enamel against the effects acid erosion.

    Dentists have reported a growing dental health concern due to changing modern diets: ‘acid erosion’. Even teeth without cavities can be affected.

    *Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker, and sensitive. 

    SENSODYNE PRONAMEL® Gentle Whitening toothpaste is formulated to protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. As it contains fluoride it also provides all the benefits of a regular toothpaste.

    † Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel has fluoride it helps protect against cavities too.

    ALWAYS FOLLOW THE LABEL

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

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2015 GSK

    105528XA

    NDC 0135-0460-01

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    DAILY PROTECTION

    STRENGTHENS AND RE-HARDENS ENAMEL

    PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

    MINTESSENCE

    NET WT 4.0 OZ (113g)

    WINE ACIDS

    FRUIT ACIDS

    SODA ACIDS

    9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

    #1 Dentist Recommended Brand for Strengthening and Protecting Enamel†

    USE WHENEVER YOU NORMALLY BRUSH

    • •Freshens breath
    • •Helps protect teeth against the effects of Acid Erosion
    • •Strengthens and re-hardens enamel
    • •Contains fluoride for cavity protection
    • •Suitable for sensitive teeth

      • ProNamel is also suitable for people with sensitive teeth.

      Help protect your enamel against the effects of acid erosion.

      *Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive.

      SENSODYNE PRONAMEL® DAILY PROTECTION toothpaste is formulated to help protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. As it contains fluoride it also provides all the benefits of a regular toothpaste.

      † Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel toothpaste has fluoride it helps protect against cavities too.

      ALWAYS FOLLOW THE LABEL

      This product contains no sugar.

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

      This product contains no sugar.

      ©2015 GSK group of companies

      105526XA

      NDC 0135-0520-01

      SENSODYNE®

      PRONAMEL®

      TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PROTECTION

      FRESH BREATH

      STRENGTHENS AND RE-HARDENS ENAMEL

      PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

      FRESH WAVE®

      NET WT 4.0 OZ (113 g)

      WINE ACIDS

      FRUIT ACIDS

      SODA ACIDS

      9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

      #1 Dentist Recommended Brand for Strengthening and Protecting Enamel†

      MULTI-ACTION

      ACID PROTECTON FORMULA

      Brushing twice a day with ProNamel® helps to:

      • •Protect enamel against the effects of acid erosion
      • •Freshen breath
      • •Strengthen and re-harden enamel
      • •Protect against cavities
      • •ProNamel is also suitable for people with sensitive teeth

        • Help protect your enamel against the effects of acid erosion.

        *Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive.

        SENSODYNE PRONAMEL® Fresh Breath toothpaste is formulated to help protect against the effects of acid erosion. It also contains fluoride providing the benefits of a regular toothpaste

        †Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel toothpaste has fluoride it helps protect against cavities too.

        ALWAYS FOLLOW THE LABEL

        GSK Consumer Healthcare

        Warren, NJ 07059

        ©2015 GSK

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

        105704XA

        NDC 0135-0568-04

        SENSODYNE®

        PRONAMEL®

        TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

        MULTI-ACTION

        STRENGTHENS AND RE-HARDENS ENAMEL

        PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

        Cleansing Mint

        WINE ACIDS

        FRUIT ACIDS

        SODA ACIDS

        NET WT 4.0 OZ (113 g)

        9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

        #1 Dentist Recommended Brand for Strengthening and Protecting Enamel†

        MULTI-ACTION

        ACID PROTECTION FORMULA

        Brushing twice a day with ProNamel® helps to:

        • •Protect enamel against the effects of acid erosion
        • •Restore natural whiteness
        • •Clean effectively and freshen breath
        • •Provide cavity protection
        • •Maintain healthy teeth and gums

          • ProNamel is also suitable for people with sensitive teeth.

          Help protect your enamel against the effects of acid erosion.

          Dentists have reported a growing dental health concern due to changing modern diets: ‘acid erosion’. Even teeth without cavities can be affected.

          *Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive.

          SENSODYNE PRONAMEL® Multi-Action toothpaste is formulated to help protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. As it contains fluoride it also provides the benefits of a regular toothpaste. Plus, its cleansing mint flavor helps keep your mouth feeling fresh and clean.

          †Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel toothpaste has fluoride it helps protect against cavities too.

          ALWAYS FOLLOW THE LABEL

          This product contains no sugar.

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

          ©2014 GSK group of companies or its licensor. All rights reserved.

          GSK Consumer Healthcare

          Warren, NJ 07059

          105689XA


* Please review the disclaimer below.