Act Kids Anticavity Fluoride Rinse
FDA Label NDC 41167-0938

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 41167-0938). 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., directions, other information, 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 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity  

Use

  • aids in the prevention of dental cavities

Keep Out Of Reach Of Children.

If more than used for rinsing is accidently swallowed, get medical help or contact Poison Control Center right away.

Directions

adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • remove cap
  • hold bottle upright and squeeze. Fill to FILL LINE
  • pour out. Only the correct 10 milliliters dose will pour out
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

    • children under 6 years of age: consult a dentist or doctor.

Other Information

  • contains FD&C yellow no.5 (tartrazine) as a color additive
  • do not use if safety seal is broken or missing

Inactive Ingredients

calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5 (309-023)

Principal Display Panel

ACT Kids
Anticavity Fluoride Rinse
 Wild Watermelon
Sodium Fluoride 0.05%
16.9 fl oz (500 mL)

Act Kidsanticavity Fluoride Rinse Wild Watermelonsodium Fluoride 0.05%16.9 Fl Oz (500 mL) (Act Kids Anticavity Fluoride Rinse Watermelon 01)

Act Kidsanticavity Fluoride Rinse Wild Watermelonsodium Fluoride 0.05%16.9 Fl Oz (500 mL) (Act Kids Anticavity Fluoride Rinse Watermelon 01)

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