DENTAL CLEAR PREMIUM- sodium fluoride rinse 
Pharmacal-International. Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Active ingredient

Sodium Fluoride (0.02%)

Purpose

  • Anticavity mouthwash

Use

  • Aids in prevention of dental cavities

Directions

  • Rinse mouth with this Dental Clear Premium about 10~15ml for 30 seconds then expel

Average daily dose

  •  Use twice a day after brushing, meals, and before social occasions.

Warnings

  • Keep out of reach of children.
  • Children under 7 years or younger must have parent supervision.
  • Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Inactive Ingredients

Water,,Glycerin,Allantoin,Acetic acid,Xylitol,Sodium acetate,Sodium Benzoate,GreenTea Extract,Malic acid,L-Menthol,Propolis Extract,Citrus flavoring,Lemon flavoring,Sodium Saccharin,Lemon Oil,Cacao Color

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DENTAL CLEAR PREMIUM 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-127
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
ACETIC ACID (UNII: Q40Q9N063P)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MALIC ACID (UNII: 817L1N4CKP)  
RACEMENTHOL (UNII: YS08XHA860)  
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
LEMON OIL (UNII: I9GRO824LL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24765-127-0111 mL in 1 POUCH; Type 0: Not a Combination Product03/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/14/2020
Labeler - Pharmacal-International. Co., Ltd. (557805060)
Registrant - Pharmacal-International. Co., Ltd. (557805060)

Revised: 8/2023
Document Id: 03245e1b-54fb-949b-e063-6294a90a4e54
Set id: 7377dcfa-c584-4360-81ce-6c46387e1454
Version: 5
Effective Time: 20230817
 
Pharmacal-International. Co., Ltd.