Freshen Up

Manufacturer
MKJ BRANDS LLC
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:02:51

Label at a glance#

ProductFreshen Up
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Potassium Nitrate 5%

Purpose

OTC - PURPOSE SECTION

Anticavity

Antihypersensitivity

Use

INDICATIONS & USAGE SECTION

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

aids in prevention of dental cavities

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and olderapply 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 underask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-880-1504

SPL UNCLASSIFIED SECTION

Dist. by:
MKJ Brands

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fuwfuw

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN2
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD2
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77782-002-13Freshen Up113 g in 1 BOTTLEGEL, DENTIFRICE1132

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77782-00277782-002-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier
ndc (package): 77782-002-13
ndc (product): 77782-002
ndc11 (package): 77782000213
spl id: 3763947b-98bb-c1f3-e063-6394a90a89ab
spl set id: 2ee626d1-6150-87db-e063-6294a90a64d8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.