Enamur Fluoride Anticavity Toothpast Paste, Dentifrice
FDA Label NDC 83610-1050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Protegera, Inc for the product Enamur Fluoride Anticavity Toothpast (NDC 83610-1050). 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 drug fact, active ingredient, purpose, use, warnings, keep out of the reach of children under 6 years of age., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Fact

Active Ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Helps protect against cavities

Warnings

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away

Keep Out Of The Reach Of Children Under 6 Years Of Age.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing habits (to minimize swallowing). Supervise children as nessary until capable of using without supervision. Children under 2 years ask a dentist or physician

Inactive Ingredients

Glycerol, Water, Hydrated Silica, Crystalline Cellulose, Cellulose, Flavor, Cocamidopropyl Betaine, Sodium Gluconate, Carbomer, Sodium Benzoate, PVM/MA Copolymer, Poloxamer 407, Xanthan Gum, Sodium Hydroxide, Benzyl Alcohol.

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Principal Dispaly Panel

ENAMUR           NDC 83610-1050-1

THE ClEANER CLEAN YOU CAN TRULY FEEL  

Fluoride AnitCavity Toothpaste

NET WT 5.2 OZ (147g)

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