Iodent Sensitive Fresh Mint
FDA Label NDC 65923-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Iodent Sensitive Fresh Mint (NDC 65923-101). 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 - stop use, otc - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, 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                                                                        Purpose

Potassium nitrate 5%--------------------------------------------------- Antihypersensitivity

Sodium fluoride (0.15% w/v fluoride ion)------------------------------Anticavity

Otc - Purpose

Uses

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

Warnings

Warnings

Otc - Stop Use

Stop use and ask a dentist if

  • the problem persists or worsens. Sensitivie teeth may indicate a serious problem that may 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 accidently swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions

adults and children 12 years of age and older

  • apply at least a 1-inch strip of product onto a soft bristle toothbruch
  • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommende 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

Storage And Handling

Other Information

  • store below 40°C (86°F)
  • Lot No & Exp Date:see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

Water, Silica, Sorbitol, Sodium Lauryl Alcohol, Polyethylene Glycol 300, Sodium Carboxymethylcellulose, Floavor, Sodium Sacchrin, Titanium Dioxide, Sodium Pyrophosphate, PEG/PPG 116/66 Copolymer, Color: Lemon Yellow & Bright Blue

Dosage & Administration

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Package Label.Principal Display Panel

Image Description (10103)

Image Description (10103)

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