FDA Label for Fluoride Mouthwash Soft Mint
View Indications, Usage & Precautions
Fluoride Mouthwash Soft Mint Product Label
The following document was submitted to the FDA by the labeler of this product Swiss Shine Beauty Ag. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients
Sodium fluoride 0.05% (0.02% w/v fluoride ion) Purpose: Anticavity
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
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