FRESHEN UP- sodium fluoride, potassium nitrate gel, dentifrice

Freshen Up by

Drug Labeling and Warnings

Freshen Up by is a Otc medication manufactured, distributed, or labeled by MKJ BRANDS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Potassium Nitrate 5%

Purpose

Anticavity

Antihypersensitivity

Use

builds increasing protection against painful sensitivity of teeth to cold, heat, acids, sweets or contact

aids in prevention of dental cavities

Warnings

Stop use and ask a dentist if the problem persists or worsens, snesitive teeth may indicate a serious problem that may need prompt care by dentist. Pain senstivity still persists after 4 weeks of use

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 12 years of age and older: apply atleast a 1-inch strip of paste onto a soft bristle toothrush. bursh atleast for 2 minutes preferably after each meal or at least twice a day, or as directed by a dentist or physician. Make sure to brush all sensitve areas of the teeth. minimizi swallowing. Spit out after brushing
• children under 12 years and under: ask a dentist or physician

Inactive ingredients

sorbitol, water, hydrated silica, PEG-32, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, cellulose gum, xlitol, sodium saccharin,titanium dioxide, benzyl alcohol,Tri sodium phosphate, sodium benzoate

Questions?

1-888-880-1504

SPL UNCLASSIFIED SECTION

Dist. by:
MKJ Brands

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHEN UP 
sodium fluoride, potassium nitrate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77782-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	24 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
XYLITOL (UNII: VCQ006KQ1E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77782-002-13	113 g in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	02/10/2025

Labeler - MKJ BRANDS LLC (827648101)