Other
Drug Facts
Fluoride Paste
FDA Label NDC 68599-9571
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 for the product Fluoride (NDC 68599-9571). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each gram)
Sodium monofluorophosphate - 0.76% (Total fluoride content - 1000 ppm approx.)
Otc - Purpose
Purpose
Anticavity
Indications & Usage
Uses
Regular brushing with fluoride toothpaste helps protect teeth against cavities.
Warnings
Warnings
Keep out of reach of children under 6 years of age.
ln case of accidental overdose, seek professional assistance or contact a Poison Control
Center immediately.
Otc - Keep Out Of Reach Of Children
Warnings
Keep out of reach of children under 6 years of age.
ln case of accidental overdose, seek professional assistance or contact a Poison Control
Center immediately.
Dosage & Administration
Directions
- Adults and children 2 years & older:
- Children under 6 years:
- Children under 2 years:
Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.
Ask a dentist or physician.
Other Safety Information
Store in a cool, dry, well-ventilated area.
Not made with natural rubber latex.
Inactive Ingredient
Inactive ingredients
Calcium Carbonate, Sorbitol, Aqua, Silica, Sodium Lauryl Sulphate, Flavour, Sodium Silicate,
Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate.
Otc - Questions
Questions? Call 1-800-777-4908
Package Label.Principal Display Panel
NDC 68599-9571-1
McKesson
MFR # 16-TPCFL15
Fluoride Toothpaste
MINT
ANTI-CAVITY WITH CALCIUM CARBONATE
Helps to protect against cavities and improve oral hygiene.
NET WEIGHT 1.5 oz (42.5 g)
C15 (Tpcfl15)
* Please review the disclaimer below.
