Mckesson Fluoride
FDA Label NDC 68599-0123

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Medical-surgical for the product Mckesson Fluoride (NDC 68599-0123). 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, use, otc - keep out of reach of children, directions, inactive 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

→ Active Ingredient

→ Purpose

→ Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Package Label.principal Display Panel

Other

Drug Facts

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.122% w/v of fluoride ion)

Purpose

Anticavity

Use

Helps protect against cavities.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician.
Children under 6 years of age: Use a pea-sized amount to minimize swallowing and supervise child's brushing until good habits are established.
Children under 2 years of age: Ask a dentist or physician.

Inactive Ingredients

calcium carbonate, purified water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxy methyl cellulose, sodium benzoate, sodium saccharin