United Dental Kit
FDA Label NDC 42509-134
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wessco International for the product United Dental Kit (NDC 42509-134). 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 drug facts, active ingredient, purpose, use, keep out of the reach of children under 6 years of age., directions, inactive ingredients, questions or comments?, 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% (0.15% w/v fluoride ion)
Purpose
Anticavity
Use
helps protect against cavities
Keep Out Of The 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 a dentist or physician |
| children 2 to 6 years | use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) |
| children under 2 years | ask a dentist or physician |
Inactive Ingredients
dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin
Questions Or Comments?
Call toll-free 1-800-468-6502
Package Labeling:Kit
Kit01 (Kit01)
Package Labeling:
Tube01 (Tube01)
Tube02 (Tube02)
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