Other
Drug Facts
Dist. by:
MKJ Brands
Freshen Up Gel, Dentifrice
FDA Label NDC 77782-005
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 77782-005). 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 Monofluorophosphate (0.76%)........Anticavity
Total Fluoride content- 1000 ppm appx.
Purpose
Anticavity
Use
helps protect against 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 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
calcium carbonate, water, sorbitol, silica, SLS, flavor, sodium silicate, tetrasodium pyrophosphate, xanthum gum, sodium carboxymethylcellulose, benzyl alcohol, sodium benzoate, sodium bicarbonate, sodium saccharin, titanium dioxide, peg-400, blue 1
Questions?
1-888-880-1504
* Please review the disclaimer below.
