Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Act Anticavity Fluoride Kids Groovy Grape Rinse
FDA Label NDC 41167-0945
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 Anticavity Fluoride Kids Groovy Grape (NDC 41167-0945). 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
Purpose
Anticavity
Use
■ 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.
■ 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
■ do not use if safety seal is broken or missing
Inactive Ingredients
benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, red 33, sodium benzoate, sodium phosphate, sorbitol, sucralose, water
Principal Display Panel
ACT
Kids
ANTICAVITY
FLUORIDE RINSE
GROOVY GRAPE
16.9 fl oz (500 mL)
Actkidsanticavityfluoride Rinsegroovy Grape16.9 Fl Oz (500 mL) (Act Anticavity Fluoride Rinse Kids Groovy Grape 01)
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