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Drug Facts
Fluoride
FDA Label NDC 68599-9572
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 68599-9572). 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 Fluoride - 0.243% (0.15% w/v fluoride ion)
Otc - Purpose
Purpose
Anticavity
Indications & Usage
Uses
Aids in the prevention of dental cavities.
Warnings
Warnings
Keep out of reach of children under 6 years of age.
If you accidentally swallow more than used for brushing, seek professional
help or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age
Dosage & Administration
Directions
Adults and children 2 years & older:
Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
Do not swallow.
Instruct children under 6 years of age in good brushing and rinsing habits
(to minimize swallowing, use a pea-sized amount).
Supervise children's brushing until good habits are established.
Children under 2 years: Consult a dentist or doctor.
Other Safety Information
Store in a cool, dry, well-ventilated area.
Inactive Ingredient
Inactive ingredients
Sorbitol, Silica, Treated Water, Glycerin, PEG-32, Sodium Lauryl Sulfate, Flavor,
Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Phosphate, Sodium Saccharin,
Sodium Benzoate, Tetrasodium Pyrophosphate, FD&C Blue # 1.
Otc - Questions
Questions? Call 1-800-777-4908
Package Label.Principal Display Panel
NDC 68599-9572-1
MFR # 16-TPFL085
NET WEIGHT 0.85 oz (24.1 g)
McKesson
Fluoride Toothpaste
MINT, ANTI-CAVITY
Helps to protect against cavities and improve oral hygiene.
085 (16 Tpfl085)
NDC 68599-9572-2
MFR # 16-TPFL15
NET WEIGHT 1.5 oz (42.5 g)
McKesson
Fluoride Toothpaste
MINT, ANTI-CAVITY
Helps to protect against cavities and improve oral hygiene.
15 (16 Tpfl15)
NDC 68599-9572-3
MFR # 16-TPFL275
NET WEIGHT 2.75 oz (78 g)
McKesson
Fluoride Toothpaste
MINT, ANTI-CAVITY
Helps to protect against cavities and improve oral hygiene.
275 (16 Tpfl275)
NDC 68599-9572-4
MFR # 16-TPFL4
NET WEIGHT 4 oz (113.4 g)
McKesson
Fluoride Toothpaste
MINT, ANTI-CAVITY
Helps to protect against cavities and improve oral hygiene.
4 (19 Tpfl4)
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