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Drug Facts
Dist. by:
MKJ Brands
Freshen Up Gel, Dentifrice
FDA Label NDC 77782-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mkj Brands Llc for the product Freshen Up (NDC 77782-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Keep Out Of Reach Of Children
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
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