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Lab52 anti-sensitivity oral care - Prescription Drug Labeling

Product NDC Code 82711-002
Drug Name

Lab52 anti-sensitivity oral care

Type Brand
Pharm Class Acidifying Activity [MoA],
Anti-coagulant [EPC],
Blood Coagulation Factor [EPC],
Calcium Chelating Activity [MoA],
Calcium [CS],
Calculi Dissolution Agent [EPC],
Cations,
Divalent [CS],
Decreased Coagulation Factor Activity [PE],
Increased Coagulation Factor Activity [PE]
Active Ingredients
Calcium lactate .2 g/100g
Potassium citrate 5.4 g/100g
Xylitol 10 g/100g
Route DENTAL
Dosage Form AEROSOL
Labeler Name TOOTHFILM INC
Packages
Package NDC Code Description
82711-002-01 15 g in 1 bottle, spray (82711-002-01)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Potassium Citrate 5.4 %、Calcium Lactate 0.2%、Xylitol 10%

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.
When you have sensitive teeth, spray 3 times on the sensitive area to help relieve the sensitivity

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Water, Glycerin, Propylene Glycol, Isomaltitol, Polysorbate 80, Lemon Flavor, Trehalose, Allantoin, Arginine, Aspalathus Linearis Extract, Sodium Bicarbonate, Ethyl Menthane Carboxamide, Sucralose, Glycyrrhiza Glabra (Licorice) Root Extract, Silica, Dicalcium Phosphate, Calcium Oxide

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.
When teeth are sensitive and sore, spray 3 times on the sore area

Purpose

Information about the drug product’s indications for use.
Relieve tooth sensitivity and soreness, tooth protection

Spl product data elements

Usually a list of ingredients in a drug product.
Lab52 Anti-Sensitivity Oral Care XYLITOL, CALCIUM LACTATE, POTASSIUM CITRATE SUCRALOSE WATER GLYCYRRHIZA GLABRA PROPYLENE GLYCOL ASPALATHUS LINEARIS LEAF SODIUM BICARBONATE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS GLYCERIN POLYSORBATE 80 ETHYL MENTHANE CARBOXAMIDE LIME (CALCIUM OXIDE) TREHALOSE SILICON DIOXIDE CALCIUM LACTATE CALCIUM CATION XYLITOL XYLITOL POTASSIUM CITRATE ANHYDROUS CITRIC ACID ISOMALTITOL ALLANTOIN ARGININE

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.
Anti-Sensitivity Oral Spray

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.
Please keep out of reach of children under 6 years old. Children under six years of age must be supervised by an adult

Storage and handling

Information about safe storage and handling of the drug product.
Store in a cool and ventilated place, avoid direct sunlight and high temperature, the shelf life is 3 years

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.
If you feel uncomfortable after using the product, please stop using it immediately and consult a professional doctor for assistance

Disclaimer: Do not rely on openFDA 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