Active Ingredient
Sodium fluoride 0.02% (0.009% w/v fluoride ion)
Act Total Care Anticavity Fluoride Fresh Mint Rinse
FDA Label NDC 41167-0943
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 Total Care Anticavity Fluoride Fresh Mint (NDC 41167-0943). 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 twice a day after brushing your teeth with a toothpaste
- remove cap
- pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
- 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
water, sorbitol, poloxamer 407, propylene glycol, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, green 3, yellow 5 (309-042)
Learn more at www. ACTFLUORIDE.com
Principal Display Panel
#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
Anticavity
Fluoride Mouthwash
alcohol free
FRESH MINT
33.8 fl oz (1 L)
#1 Dentist Recommendedfluoride Brandactanticavityfluoride Mouthwashalcohol Freefresh Mint33.8 Fl Oz (1 L) (Act Total Care Anticavity Fluoride Rinse Fresh Min 01)
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