Otc - Active Ingredient
Active Ingredients Purpose
Sodium Fluoride 0.05 (0.02% W/V fluoride ion) Anticavity
Flouride Mouthwash Strong Mint
FDA Label NDC 79763-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Swiss Shine Beauty Ag for the product Flouride Mouthwash Strong Mint (NDC 79763-001). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
- Aids in the prevention of dental cavities
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
if more than used for rinsing is accidenttally swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Do not swallow the rinse
Warnings
Warnings
Keep out of reach of children
if more than used for rinsing is accidenttally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Shake well before use
- Adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
- Vigorously swish 10 milliters of rinse between your teeth for 1 minute and then spit out.
- Do not eat or drink for 30 minutesafter rinsing.
- Instruct children under 12 year 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 Ingredient
Inactive ingredients
water, glycerin, propylene glycol, xylitol, peg-40 hydrogenated castor oil, flavor, sodium citrate,zinc lactate, poloxamer 407, chlorhexidine digluconate, citric acid, hydrochloric acid, oligopeptide-104, sodium hydroxide
Package Label.Principal Display Panel
vVardis
Switzerland
WEISSBAD
FRESH AND PROTECT
PURE WHITENING
FLUORIDE MOUTHWASH
STRONG MINT
IMPORTANT: READ DIRECTIONS FOR PROPER USE
3.4 FL OZ / 100 ml
* Please review the disclaimer below.
