Drug Facts

DENTAL CLEAR NATURAL - sodium fluoride rinse
Pharmacal-International. 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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Drug Facts

Sodium Fluoride (0.05%)

Anticavity Rinse

Keep out of reach of children.

Children under 7 years or younger must have parent supervision.

If one drank a lot of amount, drink some milk and please go see a doctor.

Keep out of reach of children.

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

Rinse mouth with this Dental Clear Natural about 10 -15 ml for 30 seconds and expel.

Water

L-Menthol

Glycerin

Acetic Acid

Sodium Acetate

Camellia Sinensis leaf Extract

Saccharin sodium

Sodium benzoate

Xylitol

Poloxamer

Citrus Medica Limonum Peel Oil

Malic Acid

Propolis Exxtract

DENTAL CLEAR NATURAL
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24765-100
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
LEVOMENTHOL (UNII: BZ1R15MTK7)
GLYCERIN (UNII: PDC6A3C0OX)
ACETIC ACID (UNII: Q40Q9N063P)
SODIUM ACETATE (UNII: 4550K0SC9B)
CAMELLIA SINENSIS ROOT (UNII: 8H54O0V2K3)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 124 (UNII: 1S66E28KXA)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
MALIC ACID (UNII: 817L1N4CKP)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24765-100-01	260 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	12/01/2011

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

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