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MKJ Brands
Freshen Up Holiday Mint Gel, Dentifrice
FDA Label NDC 77782-007
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 Holiday Mint (NDC 77782-007). 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%(0.14% w/v fluoride ion)........Anticavity
Purpose
Anticavity
Use
helps protect against cavities
Warnings
keep out of reach of childeren under 6 years of age
if more than used for brushing is accidentally swallowed , get medical help or contact a posion control center right away.
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 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, flavor, tetrasodium pyrophosphate, cellulose gum, hydroxypropl ymethylcellulose, benzyl alcohol, sodium benzoate, sodium saccharin, titanium dioxide, peg-32, blue 1,yellow 5
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