FLUORIDE- sodium fluoride paste

Fluoride by

Drug Labeling and Warnings

Fluoride by is a Otc medication manufactured, distributed, or labeled by McKesson, Dabur India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each gram)
Sodium Fluoride - 0.243% (0.15% w/v fluoride ion)

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.

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.

QUESTIONS

Questions? Call 1-800-777-4908

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.

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.

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.

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.

INGREDIENTS AND APPEARANCE

FLUORIDE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-9572
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
WATER (UNII: 059QF0KO0R)
SILICA (UNII: ETJ7Z6XBU4)
CARRAGEENAN (UNII: 5C69YCD2YJ)
CELLULOSE GUM (UNII: K679OBS311)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PEG-32 (UNII: 1212Z7S33A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-9572-1	24.1 g in 1 TUBE; Type 0: Not a Combination Product	03/23/2026
2	NDC: 68599-9572-2	42.5 g in 1 TUBE; Type 0: Not a Combination Product	03/23/2026
3	NDC: 68599-9572-3	78 g in 1 TUBE; Type 0: Not a Combination Product	03/23/2026
4	NDC: 68599-9572-4	113.4 g in 1 TUBE; Type 0: Not a Combination Product	03/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	03/23/2026

Labeler - McKesson (023904428)

Establishment
Name	Address	ID/FEI	Business Operations
Dabur India Limited		650599231	manufacture(68599-9572)