DENTAL CLEAR PREMIUM- sodium fluoride rinse

Dental Clear Premium by

Drug Labeling and Warnings

Dental Clear Premium by is a Otc medication manufactured, distributed, or labeled by Pharmacal-International. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Principal display panel

INGREDIENTS AND APPEARANCE

DENTAL CLEAR PREMIUM 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24765-127
Route of Administration	ORAL

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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24765-127-01	11 mL in 1 POUCH; Type 0: Not a Combination Product	03/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/14/2020

Labeler - Pharmacal-International. Co., Ltd. (557805060)

Registrant - Pharmacal-International. Co., Ltd. (557805060)

Establishment
Name	Address	ID/FEI	Business Operations
Greencos Co., Ltd.		694777325	manufacture(24765-127)