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|Product NDC Code||82711-007|
Lab52 kids oral protection
|Pharm Class||Blood Coagulation Factor [EPC],
Increased Coagulation Factor Activity [PE]
|Labeler Name||TOOTHFILM INC|
Active ingredientA list of the active, medicinal ingredients in the drug product.
Xylitol 10%、Calcium Lactate 0.05%
DescriptionGeneral information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Kids Oral Spray(Milk) Specially designed for children aged 0-12 to protect teeth
Dosage and administrationInformation 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.
- Spray 2 to 3 bursts of Lab52 Kids Oral Spray towards children's teeth anytime and anywhere. Do not forget to use with proper teeth brushing habit to acPlease use product within 90 days of opening.
Inactive ingredientA list of inactive, non-medicinal ingredients in a drug product.
Water, Glycerin, Sodium Levulinate, Sodium Anisate, Trehalose, Propylene Glycol, Milk Flavor, Sodium Chloride, Polysorbate 80, Milk Calcium, Dicalcium Phosphate, Silica, Calcium Oxide
Indications and usageA 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.
helps protect against cavities
PurposeInformation about the drug product’s indications for use.
Prevent Plaque Buidup Oral Care AfterNight Feeding RebairHidden Cavities
Spl product data elementsUsually a list of ingredients in a drug product.
Lab52 Kids Oral Protection XYLITOL, CALCIUM LACTATE SODIUM CHLORIDE TREHALOSE SODIUM LEVULINATE SILICON DIOXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE LIME (CALCIUM OXIDE) WATER GLYCERIN SODIUM ANISATE POLYSORBATE 80 CALCIUM LACTATE CALCIUM CATION XYLITOL XYLITOL PROPYLENE GLYCOL CALCIUM CATION
Package label principal display panelThe 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.
Recent major changesA list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.
1、Modified description of usage and dosage 2、Revise the purpose description to summarize the purpose in an easy-to-understand manner
Keep out of reach of childrenInformation 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 handlingInformation 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 - Use product within 90 days of openinglnactive
WarningsInformation 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.
- Avoid spraying in eyes. In case of contact,rinse eyes thoroughly with water. - Stop use and ask a doctor or pharmacist ifany allergic reaction to this product or anyof its ingredients Directions
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