muyme-paranmare mint 2025

muyme-paranmare mint 2025
SPL v1
SPL
SPL Set ID 4093060c-23a5-c77a-e063-6394a90a9304
Route
dental
Published
Effective Date 2025-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.32 mg)
Inactive Ingredients
xylitol sodium cocoyl isethionate eucalyptus oil limonene, (+/-)- ascorbic acid sodium chloride acacia sodium bicarbonate tocopherol pyridoxine hcl cellulose, microcrystalline stevioside menthol zinc citrate peppermint oil calcium carbonate silicon dioxide hydroxyapatite apple rosemary oil vitis vinifera seed

Identifiers & Packaging

Pill Appearance
Imprint: NONE Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-10-01

Purpose

Anti-cavity

Description

Sodium Fluoride 0.62mg (28 mg flouride ion)


Medication Information

Warnings



• Do not swallow the toothpaste tablet.

• Stop use and consult a dentist if irritation or sensitivity occurs.

• Keep out of reach of children under 6 years old.

• If more than the amount used for brushin is accidentall swallowed get advice from a doctor or contact a Poison Control Center.

Purpose

Anti-cavity

Directions
  • Adults and children 2 yrs & older: Chew 1 tablet until it breaks down, then brush teeth thoroughly at least twice a day or as directed by a dentist or physician.

    Children 2-6 yrs: Use 1 tablet under adult supervision to reduce the risk of swallowing.

    Children under 2 yrs: Ask a dentist or

Other Information

Store in a cool, dry place.

Protect from excessive heat or moisture.

See expiration date on inner

Inactive Ingredients

Xylitol, Microcrystalline Cellulose, Sodium Cocoyl Isethionate, Calcium Carbonate, Stevia Rebaudiana Extract, Acacia Senegal Gum, Hydroxyapatite, Mentha Piperita (Peppermint) Oil, Menthol, Sodium Bicarbonate, Silica, Zinc Citrate, Vitis Vinifera (Grape) Seed Extract, Pyrus Malus (Apple) Fruit Extract, Mentha Viridis (Spearmint) Leaf Oil, Tocopherol, Pyridoxine HCI, Ascorbic Acid, Rosmarinus Officinalis (Rosemary) Leaf Oil, Eucalyptus Globulus Leaf Oil, Limonene, Bamboo

Description

Sodium Fluoride 0.62mg (28 mg flouride ion)

Use

• Helps protect against cavities

• Aids in the remineralization of enamel

• Helps prevent tooth decay

Section 50565-1

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 53413-1

www.tidalove.com

Active Ingredient(s)

Sodium Fluoride 0.62mg (28 mg flouride ion)

Package Label Principal Display Panel


Structured Label Content

Warnings



• Do not swallow the toothpaste tablet.

• Stop use and consult a dentist if irritation or sensitivity occurs.

• Keep out of reach of children under 6 years old.

• If more than the amount used for brushin is accidentall swallowed get advice from a doctor or contact a Poison Control Center.

Purpose

Anti-cavity

Directions
  • Adults and children 2 yrs & older: Chew 1 tablet until it breaks down, then brush teeth thoroughly at least twice a day or as directed by a dentist or physician.

    Children 2-6 yrs: Use 1 tablet under adult supervision to reduce the risk of swallowing.

    Children under 2 yrs: Ask a dentist or

Other Information (Other information)

Store in a cool, dry place.

Protect from excessive heat or moisture.

See expiration date on inner

Inactive Ingredients (Inactive ingredients)

Xylitol, Microcrystalline Cellulose, Sodium Cocoyl Isethionate, Calcium Carbonate, Stevia Rebaudiana Extract, Acacia Senegal Gum, Hydroxyapatite, Mentha Piperita (Peppermint) Oil, Menthol, Sodium Bicarbonate, Silica, Zinc Citrate, Vitis Vinifera (Grape) Seed Extract, Pyrus Malus (Apple) Fruit Extract, Mentha Viridis (Spearmint) Leaf Oil, Tocopherol, Pyridoxine HCI, Ascorbic Acid, Rosmarinus Officinalis (Rosemary) Leaf Oil, Eucalyptus Globulus Leaf Oil, Limonene, Bamboo

Use

• Helps protect against cavities

• Aids in the remineralization of enamel

• Helps prevent tooth decay

Section 50565-1 (50565-1)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 53413-1 (53413-1)

www.tidalove.com

Active Ingredient(s)

Sodium Fluoride 0.62mg (28 mg flouride ion)

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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