Goodsense Sensitive Extra Whitening
FDA Label NDC 50804-780

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc. for the product Goodsense Sensitive Extra Whitening (NDC 50804-780). 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 - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, dosage & administration, 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

Stop use and ask a dentist if

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may prompt care by a dentist
  • pain/sensitivty still persists after 4 weeks of use

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 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
  • appy at least 1-inch strip of 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

Storage And Handling

Other information

  • store below 30°C (86°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients sorbitol, water, hydrated silica, cocamidopropyl betaine, PEG 1500, flavor, cellulose gum, titanium dioxide, sodium saccharin, menthol, tetrasodium pyrophosphate

Dosage & Administration

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

Made in Korea

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