Act Kids Anticavity Fluoride Paste
FDA Label NDC 41167-0922

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Act Kids Anticavity Fluoride (NDC 41167-0922). 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, purpose, use, keep out of reach of children under 6 years of age., directions, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Keep Out Of Reach Of Children Under 6 Years Of Age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 years of age and older:  brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 as necessary and use a pea-sized amount until your child is capable of using without supervision.
  • children under 2 years of age:  do not use unless directed by a dentist or doctor

Inactive Ingredients

water, sorbitol, hydrated silica, hydroxyethylcellulose, sucralose, flavor, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, red 33

Principal Display Panel

ACT
Kids
BUBBLE
GUM
BLOWOUT
NET WT 4.6 oz (130 g)

Principal Display Panelactkidsbubblegumblowoutnet Wt 4.6 Oz (130 G) (Act Kids Toothpaste Bubblegum Blowout 01)

Principal Display Panelactkidsbubblegumblowoutnet Wt 4.6 Oz (130 G) (Act Kids Toothpaste Bubblegum Blowout 01)

* Please review the disclaimer below.