Iodent Fluoride Mint
FDA Label NDC 68747-6032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dabur India Limited for the product Iodent Fluoride Mint (NDC 68747-6032). 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 other, active ingredient, purpose, uses, otc - keep out of reach of children, dosage & administration, ingredients, 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

Other

Drug Facts

Active Ingredient

Sodium Monofluorophospate 0.76%

(Total Fluoride Content – 1000 ppm Approx.)

Purpose

Anticavity

Uses

Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Dosage & Administration

Directions
Adults and children
2 years and older
Brush teeth thoroughly after meals or at least twice a day or use as
directed by a dentist or physician.
Children under 6 yrs To minimize swallowing use a pea-sized amount and supervise brushing
until good habits are established.
Children under 2 yrs Ask a dentist or physician.

Ingredients

Calcium Carbonate, Water, Sorbitol, Precipitated Silica, Sodium Lauryl sulphate, Flavor, Sodium Carboxy Methyl Cellulose, Sodium Silicate, Tetra Sodium Pyrophosphate, Sodium Saccharin, Methyl Paraben, Titanium Dioxide, Poly Ethylene Glycol 400, Propyl Paraben.

Package Label.Principal Display Panel

Principal Display Panel – Carton Label

IODENT® CAVITY FIGHTING TOOTHPASTE
FLUORIDE Mint Flavor
CAVITY PROTECTION & EXTRA BREATH FRESHENING
NET WT 6.4 OZ (181g)

Principal Display Panel – Carton Label (Iod01 0000 01)

Principal Display Panel – Carton Label (Iod01 0000 01)

Principal Display Panel – Tube Label

IODENT® CAVITY FIGHTING TOOTHPASTE
FLUORIDE Mint Flavor
CAVITY PROTECTION & EXTRA BREATH FRESHENING
NET WT 6.4 OZ (181g)

Principal Display Panel – Tube Label (Iod01 0000 02)

Principal Display Panel – Tube Label (Iod01 0000 02)

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