BEANGUARD GARGLE PLUS- sodium fluoride liquid 
BIO3S Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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77935-303 Beanguard Gargle Plus

Active Ingredient

Sodium Fluoride 0.05%

Purpose

Anticavity

Use

Aids in the prevention of dental cavities. Helps to refresh your breath.

Warnings

Do not use more or for longer than directed.

Warnings

This product contains fluorine, so if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Warnings

Stop use and ask a dentist if oral irritiation or tooth sensitivity occurs.

Warnings

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

Inactive Ingredients

Water, D-Sorbitol Solution, Concentrated Glycerin, Soybean Extract, Ethanol, Xylitol, Raspberry Extract, Sodium Alginate, Polyoxyethylene hydrogenated caster oil, Flavor, Sodium Benzoate, Menthol Pulegium Oil, L-Menthol, Sucralose, Sodium Fluoride, Citric acid, Sodium citrate, Green Tea Extract, Aloe Extract, Sage Extract

Other Information

Store in an airtight container at room temperature (1~30℃).

Directions

Vigorously swish 10 mL of gargle between your teeth for 1 minute and then spit it out.
Do not swallow.

Warnings

Do not swallow.

Label

Beanguard Gargle Plus Label

BEANGUARD GARGLE PLUS 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77935-303
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SOYBEAN (UNII: L7HT8F1ZOD)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PENNYROYAL OIL (UNII: AK85U7Y3MV)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ALOE (UNII: V5VD430YW9)  
CLARY SAGE (UNII: U3HSK5JC0Q)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
RASPBERRY (UNII: 4N14V5R27W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77935-303-01250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/2022
2NDC:77935-303-0210 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/08/2022
Labeler - BIO3S Co.,Ltd. (694813103)

Revised: 4/2022
Document Id: dc1c793b-b637-f13a-e053-2995a90ace61
Set id: dc1c793b-b636-f13a-e053-2995a90ace61
Version: 1
Effective Time: 20220407
 
BIO3S Co.,Ltd.