Purpose
Sodium fluoride 0.02% (0.009% w/v fluoride ion)..........................................................................................Anticavity
Act Whitening Anticavity Gentle Mint Mouthwash
FDA Label NDC 41167-0983
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 Whitening Anticavity Gentle Mint (NDC 41167-0983). 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 purpose, use, stop use and ask a dentist if, 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
Use
■ aids in the prevention of dental cavities
Stop Use And Ask A Dentist If
oral irritation or tooth sensitivity occurs
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 12 years of age and older:
■ use twice a day after brushing your teeth with a toothpaste
■ vigorously swish 10 milliliters (2 teaspoonfuls) 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
■ supervise children as necessary until capable of using without supervision
children under 12 years of age: consult a dentist or doctor
Other Information
■ do not use if safety seal is broken or missing
Inactive Ingredients
water, glycerin, xylitol, hydrogen peroxide, poloxamer 407, propylene glycol, pentylene glycol, flavors, sodium benzoate, sodium phosphate, disodium phosphate, 4-t-butylcyclohexanol, menthol, sucralose, sodium saccharin, calcium disodium EDTA
Principal Display Panel
ACT
WHITENING
ANTICAVITY FLUORIDE MOUTHWASH
GENTLE MINT
16.9 fl oz (500 mL)
Principal Display Panelactwhiteninganticavity Fluoride Mouthwashgentle Mint16.9 Fl Oz (500 mL) (Act Whitening Anticavity Fluoride Mouthwash Gentle 01)
Principal Display Panelactwhiteninganticavity Fluoride Mouthwashgentle Mint16.9 Fl Oz (500 mL) (Act Whitening Anticavity Fluoride Mouthwash Gentle 02)
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