FDA Label for Sensitive Whitening With Baking Soda

View Indications, Usage & Precautions

Sensitive Whitening With Baking Soda Product Label

The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. 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.

Otc - Active Ingredient



Active ingredients        
Potassium nitrate 5.0%
Sodium fluoride 0.243%


Otc - Purpose



PurposeAntihypersensitivityAnticavity toothpaste

Indications & Usage



Use 

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


Warnings



Warnings
When using this product
do not use longer than 4 weeks unless recommended by a dentist or physician.

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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions    do not swallow   

adults and children 12 years and older

  • apply at least a 1-inch strip of the product onto a soft bristly toothbrush. Brush teeth for at least one minute, preferable after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician.  Make sure to brush all sensitive areas of the teeth.
  • children under 12 years

    • consult a dentist or physician

Inactive Ingredient



Inactive ingredients   sodium bicarbonate (baking soda), water, sorbitol, glycerin, hydrated silica, flavor, sodium saccharin, sodium lauroyl sarcosinate, sodium lauryl sulfate, cellulose gum, titanium dioxide, xanthan gum


Otc - Questions



Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET or visit www.myoralcare.com


Principal Display Panel




ARM AND HAMMER The Standard of Purity
Fluoride Anti-Cavity Toothpaste    Frosted Mint Flavor

Sensitive                  From the Makers of
                                     Orajel

                Maximum Relief Without a Prescription

NET WT.                                               
4.5 OZ. (127g)           Whitening          with Baking Soda                 

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