Active Ingredient
Potassium Nitrate 5%
Sodium Fluoride 0.1%
Sensitivity Toothpastes
FDA Label NDC 84117-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Hengkaifeng Commerce And Trade Co., Ltd for the product Sensitivity Toothpastes (NDC 84117-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, keep out of reach of children, directions of safe use, inactive ingredients, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihypersensitivity
Anticavity
Use
● builds increasing protection against painful sensitivity of the teeth to cold, heat, acids,
sweets, or contact.
● alds in the prevention cf dental cavities.
Warnings
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
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 Of Safe Use
● 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.
Inactive Ingredients
water, hydrated silica, glycerin, sorbitol, ethyl menthane carboxamide, titanium
dioxide, cellulose gum, sodium saccharin, sucralose
Dosage & Administration
apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
Package Label.Principal Display Panel
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