Propolimix
FDA Label NDC 24765-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacal-international. Co., Ltd. for the product Propolimix (NDC 24765-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients                                                                 purpose, purpose, use, warnings, directions, inactive ingredients, storage method, expiration date, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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

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