Go Smile
FDA Label NDC 44873-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Go Smile, Inc. for the product Go Smile (NDC 44873-008). 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 purpose, otc - keep out of reach of children, directions, inactive ingredients, uses, active ingredients, warnings, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

ANTICAVITY

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.

Directions

Adults and children 2 years of age or older – Brush teeth thoroughly for 2 minutes at least twice a day preferably after each meal or as directed by a dentist or doctor.
Children under 6 years of age – Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years of age – Consult a dentist or doctor

Inactive Ingredients

Water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, sodium ascorbyl phosphate, tocopherol, retinyl palmitate, aloe barbadensis leaf juice, flavor, sodium lauryl sulfate, sodium methyl cocoyl taurate, sodium saccharin, cellulose gum, titanium dioxide

Uses

Aids in the prevention of dental cavities

Active Ingredients

​Sodium Fluoride 0.24% (w/w)

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Other Information

STORE AT ROOM TEMPERATURE.

Package Label.Principal Display Panel

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