Kids Choice Gel, Dentifrice
FDA Label NDC 63783-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Massco Dental A Division Of Dunagin Pharmaceuticals for the product Kids Choice (NDC 63783-005). 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, inactive ingredients, use, keep out of reach of children, directions for use, other information, questions ? comments ?, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Inactive Ingredients

→ Use

→ Keep Out Of Reach Of Children

→ Directions For Use

→ Other Information

→ Questions ? Comments ?

→ Warnings

→ Package Label

Active Ingredient

Active Ingredient: Stannous Fluoride

Inactive Ingredients

Glycerine, Hydroxy Ethyl Celluulose, Xylitol

Use

Aids in the prevention of dental decay.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Directions For Use

Adults and Children 12 years and Older: Use after regular brushing and flossing. Place gel across length of toothbrush. Brush Thoroughly. Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out). Do not swallow. Use once a day for cavity prevention. Supervise children until capable of using without supervision.

Children 6-11 Years: See directions above. Adult supervision required.

Children Under 6: Consult a Dentist or Physician.

Other Information

This is a fluoride prevention treatment gel, not a toothpaste. Read directions carefully before use. This product may produce surface discoloration of the teeth. Adequate toothbrushing may prevent discoloration. Discoloration is not harmful or permanent and may be removed by a dental professional. Do not freeze or expose to extreme heat.