Lornamead Paste, Dentifrice
FDA Label NDC 62721-0470

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 Products for the product Lornamead (NDC 62721-0470). 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, uses, 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.

Active Ingredient

Potassium nitrate 5% ................................................... Antisensitivity

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • 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. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute, twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.

Do not swallow

Dosage & Administration

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.

Other Information

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

Inactive Ingredients

Water, Hydrated Silica, Sorbitol, Glycerin, Cocamidopropyl Betaine, PEG-12, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin, Red 40

Package Label.Principal Display Panel

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Carton Label (Mm1)

Carton Label (Mm1)

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Tube Label (Mm2)

Tube Label (Mm2)

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