Act Kids Pure Protect Anticavity- Simply Strawberry Rinse
FDA Label NDC 41167-0915

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 Pure Protect Anticavity- Simply Strawberry (NDC 41167-0915). 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 ingredients, purpose, uses, keep out of reach of children., 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 Ingredients

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Uses

■ aids in the prevention of dental cavities

Keep Out Of Reach Of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a 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 (10mL)
  • 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

Inactive Ingredients

cetylpyridinium chloride, dipotassium glycyrrhizinate, disodium phosphate, flavor, glycerin, poloxamer 407, polysorbate 20, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, stevia rebaudiana leaf/stem extract, water, xylitol

Principal Display Panel

ACT
Kids
Anticavity
Fluoride Rinse
Simply
Strawberry
16.9 fl oz (500 mL)

Principal Display Panelactkidsanticavityfluoride Rinsesimplystrawberry16.9 Fl Oz (500 mL) (Act Kids Pure Protect Anticavity Mouthwash Simple 01)

Principal Display Panelactkidsanticavityfluoride Rinsesimplystrawberry16.9 Fl Oz (500 mL) (Act Kids Pure Protect Anticavity Mouthwash Simple 01)

Principal Display Panelactkidsanticavityfluoride Rinsesimplystrawberry16.9 Fl Oz (500 mL) (Act Kids Pure Protect Anticavity Mouthwash Simple 02)

Principal Display Panelactkidsanticavityfluoride Rinsesimplystrawberry16.9 Fl Oz (500 mL) (Act Kids Pure Protect Anticavity Mouthwash Simple 02)

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