Sensitive Paste, Dentifrice
FDA Label NDC 54473-302

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Sensitive (NDC 54473-302). 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, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients
Potassium nitrate (5.0% w/w)
Sodium fluoride (0.243% w/w)

Otc - Purpose

Purpose
Antisensitivity
Anticavity

Indications & Usage

Uses

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

Warnings

Warnings
When using this product do not use longer than four weeks unless recommended by a dentist

Otc - Stop Use

Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.

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

Directions

  • adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, preferably 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 of age: consult a dentist or physician

Precautions

Other information

This product contains papain, which may cause allergic reactions

Inactive Ingredient

Inactive ingredients aloe barbadensis juice powder, ascorbyl palmitate, camellia sinensis leaf extract, chondurs crispus (carrageenan), commiphora myrrha oil, flavor, glycerin, hydrated sisica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrphosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol, zinc citrate

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