FRESHEN-UP MATCHA 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 ion)........Anticavity

Purpose

Anticavity

Use

helps protect against cavities

Warnings

keep out of reach of chilren under 6 yeras of age

if more than used for brushing is accidently 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, celluose gum,titanium dioxide, benzyl alcohol, sodium benzoate, trisoudium phosphate, sodium saccharin, peg-32, blue 1,yellow 5

Questions?

1-888-880-1504

SPL UNCLASSIFIED SECTION

Dist. by:
MKJ Brands

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHEN-UP MATCHA MINT 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77782-011
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
YELLOW 5 (UNII: I753WB2F1M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PEG-32 (UNII: 1212Z7S33A)
CELLULOSE GUM (UNII: K679OBS311)
TETRASODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
CI 42090 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77782-011-20	1 in 1 BOX	01/02/2026
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	01/02/2026

Labeler - MKJ BRANDS LLC (827648101)

Registrant - MKJ BRANDS LLC (827648101)

Establishment
Name	Address	ID/FEI	Business Operations
Dabur India Limited		650599231	manufacture(77782-011)