BRUSH BUDDIES ORAL RINSE SPARKLE MINT- sodium fluoride mouthwash

Brush Buddies Oral Rinse Sparkle Mint by

Drug Labeling and Warnings

Brush Buddies Oral Rinse Sparkle Mint by is a Otc medication manufactured, distributed, or labeled by ASHTEL STUDIOS, INC, Vasu Healthcare Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Fluoride 0.05% (0.02%w/v fluoride ion)

Purpose

Anti-cavity

Uses:

Helps prevent dental cavities

Warnings

Stop use and ask dentist if

• Gingivitis, bleeding or redness persists for more than 2 weeks.
• You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

If more than the rinsing amount is swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 18 years and older:Measure 10ml (2 teaspoonful) and vigorously swish around the mouth and between teeth for about 1 minute and expel. Use undiluted, once daily, in morning, after brushing with a toothpaste. Do not eat or drink for atleast 30min. after rinsing.
• Do not swallow.

Other information

• Do not exceed the recommended dosage.
• This rinse is not a substitute for brushing or flossing.
• Do not use if safety seal is broken or missing.

Inactive ingredients

Water, Glycerine, PEG-40 Hydrogenated Castor Oil, Menthol, Citrus Lemon Peel Oil, Mentha Piperita Oil, Thymol, Sodium Benzoate, Sucralose, Xylitol, Sodium Bicarbonate, Citric acid, Sodium Chlorite, Flavour

Questions or comments?

Call toll free 1-877-274-8358

Package Label

INGREDIENTS AND APPEARANCE

BRUSH BUDDIES ORAL RINSE SPARKLE MINT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-206
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
THYMOL (UNII: 3J50XA376E)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORITE (UNII: G538EBV4VF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-206-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/01/2025

Labeler - ASHTEL STUDIOS, INC (148689180)

Registrant - Vasu Healthcare Pvt. Ltd. (930225721)