FLUORIDE MOUTHWASH SOFT MINT- sodium fluoride mouthwash

Fluoride Mouthwash Soft Mint by

Drug Labeling and Warnings

Fluoride Mouthwash Soft Mint by is a Otc medication manufactured, distributed, or labeled by Swiss Shine Beauty AG, System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH, Marvinpac SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Sodium fluoride 0.05% (0.02% w/v fluoride ion) Purpose: Anticavity

PURPOSE

Use

• Aids in the prevention of dental cavities.

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

651 N. Broad St., Middletown, DE 19709

• Tamper evident: Do not use if safety seal is broken or missing.

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

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

INGREDIENTS AND APPEARANCE

FLUORIDE MOUTHWASH SOFT MINT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79763-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ZINC LACTATE (UNII: 2GXR25858Y)
POLOXAMER 407 (UNII: TUF2IVW3M2)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
HYDROCHLORIC ACID (UNII: QTT17582CB)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79763-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/21/2020

Labeler - Swiss Shine Beauty AG (480422958)

Establishment
Name	Address	ID/FEI	Business Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH		328825757	manufacture(79763-002)

Establishment
Name	Address	ID/FEI	Business Operations
Marvinpac SA		482060329	pack(79763-002)