Oro Min

Oro Min
SPL v1
SPL
SPL Set ID 51d8d5bd-baba-44c3-e054-00144ff88e88
Route
DENTAL
Published
Effective Date 2017-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphate Ion (2 g) Calcium Cation (0.005 g) Fluoride Ion (0.06 g)
Inactive Ingredients
Alcohol Propylparaben Methylparaben Disodium Ethylenediaminediacetate Sodium Chloride Saccharin Sodium Water Sorbitol Polysorbate 80 Polysorbate 20 Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-06-16

Description

Oro Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.


Medication Information

Warnings and Precautions

Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.

Description

Oro Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Section 55105-1

ORO Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

Directions:

After brushing and flossing, rinse 10-15 mL of ORO Min (fill cap 3/4 full) between teeth for 60 seconds, then spit out. Do not swallow. Do not eat or drink for 30 minutes after rinsing. Use twice a day or as directed by your dentist or hygienist.

Recommended Use:

Oro Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

Medicinal Ingredient:

Calcium chloride 0.054%, sodium fluoride 0.02%, sodium phosphate 0.056%

Non Medicinal Ingredients:

Water, ethyl alcohol, sorbitol solution, sodium chloride, edetate disodium, sodium benzoate, polysorbate 20, polysorbate 80, methyl paraben, sodium saccharin, propyl paraben, and flavouring agent.


Structured Label Content

Warnings and Precautions (34071-1)

Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

ORO Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

Directions:

After brushing and flossing, rinse 10-15 mL of ORO Min (fill cap 3/4 full) between teeth for 60 seconds, then spit out. Do not swallow. Do not eat or drink for 30 minutes after rinsing. Use twice a day or as directed by your dentist or hygienist.

Recommended Use: (Recommended use:)

Oro Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

Medicinal Ingredient: (Medicinal ingredient:)

Calcium chloride 0.054%, sodium fluoride 0.02%, sodium phosphate 0.056%

Non Medicinal Ingredients: (Non-Medicinal Ingredients:)

Water, ethyl alcohol, sorbitol solution, sodium chloride, edetate disodium, sodium benzoate, polysorbate 20, polysorbate 80, methyl paraben, sodium saccharin, propyl paraben, and flavouring agent.


Advanced Ingredient Data


Raw Label Data

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