PROPOLIMIX- sodium fluoride, allantoin liquid

Propolimix by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients                                                                 Purpose

SODIUM FLUORIDE 0.02% ……..…………………………………………..…………Anticavity
Allantoin 0.2% ……………………………………………………………………...…..……Antigingivitis

Purpose

Anticavity, Antigingivitis, Clean mouth

Use

• Aids in prevention of dental cavities.
• Helps prevent and reduce plague (antiplague).
• Helps to remove bad breath.

Warnings

• Be careful not to swallow and rinse your mouth thoroughly after use.
• Stop use and ask a dentist if oral irritation or tooth sensitivity occurs
• Keep out of reach of children under the age of six, and if children under the age of six swallow large amounts, contact your doctor or dentist immediately.

KEEP OUT OF REACH OF CHILDREN

Directions

Rinse mouth with this about 10~15ml for 30 seconds then expel

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

Inactive Ingredients

Glycerin, Xylitol, Sodium saccharin, Chitosan, Sodium benzoate, Citric acid, Sodium citrate, DL-malic acid, Acetic acid, Greentea extract, Turmeric extract, Ginger tincture, Propolis extract, Flavoring, Peppermint oil, L-menthol, Caramel coloring, Purified water

Storage method

storage at room temperature (1~30℃)

Expiration date

Separately marked

Product label

INGREDIENTS AND APPEARANCE

PROPOLIMIX 
sodium fluoride, allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24765-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLIGLUSAM (UNII: 82LKS4QV2Y)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALIC ACID (UNII: 817L1N4CKP)
ACETIC ACID (UNII: Q40Q9N063P)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TURMERIC (UNII: 856YO1Z64F)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
PEPPERMINT OIL (UNII: AV092KU4JH)
2-(L-MENTHOXY)ETHANOL (UNII: 5ZWW23169H)
CARAMEL (UNII: T9D99G2B1R)
WATER (UNII: 059QF0KO0R)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24765-002-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/18/2024

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