Otc - Active Ingredient
Active Ingredients
Sodium fluoride 0.05% (0.02% w/v fluoride ion) Purpose: Anticavity
Fluoride Mouthwash Soft Mint
FDA Label NDC 79763-002
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 Fluoride Mouthwash Soft Mint (NDC 79763-002). 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, other safety information, inactive ingredient, 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 accidently swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Do not swallow the rinse
Warnings
Keep out of reach of children.
If more than used for rinsing is accidently 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 yout teeth with a toothpaste.
- 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 Safety Information
- You may report serious side effects to: Swiss Shine Beauty, Inc
- Tamper evident: Do not use if safety seal is broken or missing.
651 N. Broad St., Middletown, DE 19709
Inactive Ingredient
Inactive ingredients
water, glycerin, propylene glycol, xylitol, peg-40 hydrogenated castor oil, sodium citrate, flavor, 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
SOFT MINT
IMPORTANT: READ DIRECTIONS FOR PROPER USE
3.4 FL OZ / 100 ml e
100 Fluoride Mouthwash (200625 Vvardis Weissbad Spm Print Page 1)
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