paranmare-muyme cinnamon2025

paranmare-muyme cinnamon2025
SPL v1
SPL
SPL Set ID 4092fcbf-27f7-b067-e063-6394a90a41c6
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
cinnamon oil ascorbic acid limonene, (+/-)- sodium cocoyl isethionate calcium carbonate silicon dioxide sodium chloride apple zinc citrate stevioside xylitol cellulose, microcrystalline menthol pyridoxine hcl rosemary oil sodium bicarbonate vitis vinifera seed tocopherol tribasic calcium phosphate peppermint oil acacia

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

Anticavity

Description

Sodium Fluoride 0.32% 1450 ppm fluoride 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 brushing is accidentally swallowed, get advice from a doctor or contact a Poison Control Center.

Purpose

Anticavity

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 physician.

Other Information

Store in a cool, dry place.

Protect from excessive heat or moisture.

See expiration date on inner package.

Inactive Ingredients

Xylitol, Microcrystalline Cellulose, Sodium Cocoyl Isethionate, Calcium Carbonate, Flavor (Natural Cinnamon Flavor), Stevia Rebaudiana Extract, Acacia Senegal Gum, Hydroxyapatite, Mentha Piperita (Peppermint) Oil, Sodium Bicarbonate, Silica, Zinc Citrate, Vitis Vinifera (Grape) Seed Extract, Pyrus Malus (Apple) Fruit Extract, Menthol, Tocopherol, Pyridoxine HCI,

Ascorbic Acid, Rosmarinus Officinalis (Rosemary) Leaf Oil, Eucalyptus Globulus Leaf Oil, Limonene, Bamboo Salt

Description

Sodium Fluoride 0.32% 1450 ppm fluoride 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 0.32% 1450 ppm fluoride 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 brushing is accidentally swallowed, get advice from a doctor or contact a Poison Control Center.

Purpose

Anticavity

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 physician.

Other Information (Other information)

Store in a cool, dry place.

Protect from excessive heat or moisture.

See expiration date on inner package.

Inactive Ingredients (Inactive ingredients)

Xylitol, Microcrystalline Cellulose, Sodium Cocoyl Isethionate, Calcium Carbonate, Flavor (Natural Cinnamon Flavor), Stevia Rebaudiana Extract, Acacia Senegal Gum, Hydroxyapatite, Mentha Piperita (Peppermint) Oil, Sodium Bicarbonate, Silica, Zinc Citrate, Vitis Vinifera (Grape) Seed Extract, Pyrus Malus (Apple) Fruit Extract, Menthol, Tocopherol, Pyridoxine HCI,

Ascorbic Acid, Rosmarinus Officinalis (Rosemary) Leaf Oil, Eucalyptus Globulus Leaf Oil, Limonene, Bamboo Salt

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 0.32% 1450 ppm fluoride ion

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


Advanced Ingredient Data


Raw Label Data

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