OLIDENTAL CHECK GARGLE- 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 (0.02%)

Anticavity Rinse

Keep out of reach of children.

Children under 6 years or younger must have parent supervision.

The amount of Sodium Floride is 90.5 ppm.

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

Keep out of reach of children.

Use this product after meal.

Rinse mouth with this Product about 10 -15 ml for 30 seconds and expel.

Water

Glycerin

Propolis Extract

Citric Acid

Allantoin

Camellia Sinensis Leaf Extract

Xylitol

Sodium Benzoate

Sodium Citrate

Malic Acid

Fragrance

caramel

L-Menthol

Lemon Oil

Olive Leaf Extract

Saccharin Na

Olidental

OLIDENTAL CHECK GARGLE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24765-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0154 g in 770 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALLANTOIN (UNII: 344S277G0Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MALIC ACID (UNII: 817L1N4CKP)
CARAMEL (UNII: T9D99G2B1R)
LEVOMENTHOL (UNII: BZ1R15MTK7)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
SACCHARIN N-(2-ACETIC ACID ETHYL ESTER) (UNII: KN712V27AV)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24765-101-01	770 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/26/2014	05/20/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	12/01/2011	05/20/2021

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Greencos Co., Ltd.		694777325	manufacture(24765-101)

Revised: 5/2021

Document Id: c33d4068-305a-f0d0-e053-2a95a90a94d8

Set id: 925ed715-4fe0-4fb1-bf04-229b7c58f836

Version: 5

Effective Time: 20210526

Pharmacal-International. Co., Ltd.