Lornamead
FDA Label NDC 62721-0472

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lornamead for the product Lornamead (NDC 62721-0472). 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 active ingredient, use, warnings, otc - keep out of reach of children, directions, dosage & administration, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.24% w/w..................................................Anticavity

Use

  • aids in the prevention of dental cavities

Warnings

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. Stop use and ask a dentist if the sensitivity problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day or as recommended by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.

Dosage & Administration

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day or as recommended by a dentist or doctor. Children under 2 years of age: consult a dentist or doctor.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive Ingredients

Water, Hydrated Silica, Sorbitol, Glycerin, PEG-12, Titanium Dioxide, Flavor, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin. Sodium Benzoate,

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