Other
Drug Facts
Other information
- Store at room temperature
Distributed by: LEC Custom Products, Inc, Missisauga, ON L5S 1B8
MADE IN CANADA
Percara Kids Bubble Gum Rinse
FDA Label NDC 67933-0016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lec Custom Products, Inc. for the product Percara Kids Bubble Gum (NDC 67933-0016). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients
Sodium fluoride 0.05% (Fluoride ion-0.0226%)
Otc - Purpose
Purpose
Anticavity rinse
Indications & Usage
Uses
aids the prevention of dental cavities
Warnings
Warning
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions
- adults and children 6 years of age and older, use once a day after brushing your teeth with a toothpaste
- Remove cap
- Use approximately one tablespoon and rinse vigorously between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- instruct children under 12 years of age in good rinsing habits
- supervise children as necessary until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
Inactive Ingredient
Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene plycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water
Package Label.Principal Display Panel
PERCARA™
ALCOHOL FREE
CAVITY PROTECTION
kids BUBBLE GUM
FLUORIDE RINSE
18 FL OZ (532 ML)
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