Denti-care
FDA Label NDC 64778-1377

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ar Medicom Inc for the product Denti-care (NDC 64778-1377). 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 description, dosage & administration, inactive ingredient, warnings and precautions, other, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Denti-Care

Denti-Foam

Topical Fluoride Foam Orange

1.23 % Fluoride Ions

4.4 oz / 125 g

NDC 64778-1377-1


Dosage & Administration



A topical anti-caries preparation

Directions (for professional use only):

1. Use after thorough prophylaxis

2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

Note: fill tray(s) at one quarter full to allow foam to expand

3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

4. Remove tray(s) and have patient expectorate excess

5. Advise patient not to eat, drink or rinse for 30 minutes after the application

130 applications

Medicinal ingredients:

Fluoride ions 1.23 % w/w (from 1.76 % sodium fluoride and 1.04% hydrofluoric acid)



Inactive Ingredient

Non-Medicinal ingredients: sodium saccharin, sodium benzoate, plasdone C30, glycerin USP, propylene glycol, polysorbate 20, stepanol WA 100, phosphoric acid, purified water, orange flavor

Warnings And Precautions

Warnings: KEEP OUT OF REACH OF CHILDREN

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

Do not use if seal is broken.

Rx Only

Other

Manufactured in Canada forAR Medicom Inc Montreal, Canada, H8T 3J8Questions 1-800-361-2862 or www.medicom.comUPC 686864008651Item code 10037-ORev 00

Package Label.Principal Display Panel

10037foamo (10037foamo)

10037foamo (10037foamo)

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