FLUORIDE- fluoride toothpaste 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 monofluorophosphate - 0.76% (Total fluoride content - 1000 ppm approx.)

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.

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:

Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.

• Children under 6 years:

To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.

• Children under 2 years:

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.

QUESTIONS

Questions? Call 1-800-777-4908

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)

INGREDIENTS AND APPEARANCE

FLUORIDE 
fluoride toothpaste paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-9571
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM SILICATE (UNII: IJF18F77L3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SILICA (UNII: ETJ7Z6XBU4)
TETRASODIUM PYROPHOSPHATE (UNII: O352864B8Z)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-9571-1	1 g in 1 TUBE; Type 0: Not a Combination Product	03/05/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	03/05/2026

Labeler - McKesson (023904428)

Establishment
Name	Address	ID/FEI	Business Operations
Dabur India Limited		650599231	manufacture(68599-9571)