Otc - Active Ingredient
Potassium nitrate 5% ...................................................... Anthihypersensitivity
Sodium Fluoride 0.24% (0.15% w/v fluoride ion) .............Anticavity
Heb Sensitive Extra Whitening Twin Paste, Dentifrice
FDA Label NDC 37808-237
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heb for the product Heb Sensitive Extra Whitening Twin (NDC 37808-237). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antihypersensitivity
Anticavity
Warnings
When using this product, if irritation occurs discontinue use.
Otc - When Using
When using this product, if irritation occurs discontinue use.
Otc - Stop 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.
Otc - 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.
Dosage & Administration
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 one 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.
Indications & Usage
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 one 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 Ingredient
water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin
Otc - Questions
Questions or comments? 1-877-777-2743
Package Label.Principal Display Panel
Heb_sensitive_whitening_carton_2pk_2921097r1 (Heb Sensitive Whitening Carton 2pk 2921097r1)
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