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Kaylaan - Medication Information

Product NDC Code 82091-115
Drug Name

Kaylaan

Type Brand
Active Ingredients
Sodium fluoride .37 mg/440mg
Route DENTAL
Dosage Form TABLET, CHEWABLE
Application Number part355
Labeler Name Kaylaan LLC
Packages
Package NDC Code Description
82091-115-01 74.3 mg in 1 box, unit-dose (82091-115-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
OTC-ACTIVE INGREDIENT SECTION

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DOSAGE & ADMINSTRATION SECTION

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENT SECTION

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
INDICATIONS & USAGE SECTION

Purpose

Information about the drug product’s indications for use.
OTC - PURPOSE SECTION

Spl product data elements

Usually a list of ingredients in a drug product.
KAYLAAN Zero Waste Refill For Toothpaste XANTHAN GUM SODIUM FLUORIDE FLUORIDE ION STEVIA LEAF MINT MAGNESIUM STEARATE ERYTHRITOL XYLITOL SODIUM COCOYL ISETHIONATE CINNAMON CALCIUM CARBONATE SODIUM BICARBONATE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
OTC-KEEP OUT OF REACH OF CHILDREN SECTION

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
WARNINGS SECTION

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API