Fluoride
- Manufacturer
- McKesson | Dabur India Limited
- Effective date
- 2026-03-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:58:57
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each gram)
Sodium Fluoride - 0.243% (0.15% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose
Anticavity
INDICATIONS & USAGE SECTION
Uses
Aids in the prevention of dental cavities.
WARNINGS SECTION
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 SECTION
Keep out of reach of children under 6 years of age
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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 SECTION
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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.
Products#
Every source-derived product name is available through these pages.
- Fluoride
- Sodium Fluoride
- TITANIUM DIOXIDE
- DISODIUM PHOSPHATE
- SODIUM BENZOATE
- SODIUM SACCHARIN
- SORBITOL
- GLYCERIN
- SODIUM LAURYL SULFATE
- SODIUM PYROPHOSPHATE
- WATER
- SILICA
- CARRAGEENAN
- FLUORIDE ION
- CELLULOSE GUM
- FD&C BLUE NO. 1
- PEG-32
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68599-9572 | 68599-9572-1, 68599-9572-2, 68599-9572-3, 68599-9572-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DISODIUM PHOSPHATE | 22ADO53M6F | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM SACCHARIN | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SODIUM PYROPHOSPHATE | O352864B8Z | IACT |
| WATER | 059QF0KO0R | IACT |
| SILICA | ETJ7Z6XBU4 | IACT |
| CARRAGEENAN | 5C69YCD2YJ | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| CELLULOSE GUM | K679OBS311 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| PEG-32 | 1212Z7S33A | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5025cf17-50b6-05b0-e063-6394a90a3c39 | 4db156b5-fbe8-e753-e063-6394a90a2e17 | 2026-04-23 | Warnings | 4db156b5-fbe8-e753-e063-6394a90a2e17 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.



