FRESHEN UP VANILLA MINT- sodium fluoride gel, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (0.14% W/V FLUORIDE IRON)........Anticavity

Purpose

Anticavity

Use

helps protect against cavities

Warnings

kEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE

if more than used for brushing is accidentally swallowed, get medical help or contact a posion control right away.

Keep out of reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by physician or dentist
• children 2 to 6 years: use only a pea siz amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask a dentist or physician

Inactive ingredients

water, sorbitol, silica, SLS, flavor, sodium silicate, tetrasodium pyrophosphate, cellulose gum, sodium lauryl sulfate, benzyl alcohol, sodium benzoate, hydroxypropyl methylcellulose, iron oxide amber, menthol ,sodium saccharin, titanium dioxide, red-40, blue 1,yellow 5

Questions?

1-888-880-1504

SPL UNCLASSIFIED SECTION

Dist. by:
MKJ Brands

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHEN UP VANILLA MINT 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77782-006
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
CELLULOSE GUM (UNII: K679OBS311)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
FERRIC OXIDE (UNII: 1K09F3G675)
TETRASODIUM PYROPHOSPHATE (UNII: O352864B8Z)
MENTHOL (UNII: L7T10EIP3A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CI 42090 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77782-006-20	1 in 1 BOX	05/21/2026
1		113 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/21/2026

Labeler - MKJ BRANDS LLC (827648101)