Active Ingredient(S)
Sodium Fluoride 0.62mg (28 mg flouride ion)
Tidalove Tablet, Chewable
FDA Label NDC 82756-222
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Paranmare Llc for the product Tidalove (NDC 82756-222). 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 ingredient(s), purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-cavity
Use
• Helps protect against cavities
• Aids in the remineralization of enamel
• Helps prevent tooth decay
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.
Otc - Keep Out Of Reach Of Children
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
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
Otc - Questions
www.tidalove.com
Package Label - Principal Display Panel
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