SPL UNCLASSIFIED SECTION
Drug Facts
PerCara Kids Bubble Gum
- Manufacturer
- LEC Custom Products, Inc. | LEC Custom Products, Inc
- Effective date
- 2024-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:07:15
Label at a glance#
ProductPerCara Kids Bubble Gum
Active ingredientSODIUM FLUORIDE
Label structure10 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Sodium fluoride 0.05% (Fluoride ion-0.0226%)
OTC - PURPOSE SECTION
Purpose
Anticavity rinse
INDICATIONS & USAGE SECTION
Uses
aids the prevention of dental cavities
WARNINGS SECTION
Warning
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 SECTION
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 SECTION
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
SPL UNCLASSIFIED SECTION
Other information
- Store at room temperature
SPL UNCLASSIFIED SECTION
Distributed by: LEC Custom Products, Inc, Missisauga, ON L5S 1B8
MADE IN CANADA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PERCARA™
ALCOHOL FREE
CAVITY PROTECTION
kids BUBBLE GUM
FLUORIDE RINSE
18 FL OZ (532 ML)
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67933-0016-1 | PerCara Kids Bubble Gum | 532 mL in 1 BOTTLE, PLASTIC | RINSE | 532 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67933-0016 | PERCARA KIDS BUBBLE GUM (SODIUM FLUORIDE) RINSE [LEC CUSTOM PRODUCTS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240116_be3a7272-acfb-7d14-e053-2995a90a9420.zip |
Products#
Every source-derived product name is available through these pages.
- PerCara Kids Bubble Gum
- Sodium fluoride
- BENZYL ALCOHOL
- EDETATE CALCIUM DISODIUM ANHYDROUS
- CETYLPYRIDINIUM CHLORIDE
- POLOXAMER 407
- POLYSORBATE 80
- PROPYLENE GLYCOL
- D&C RED NO. 33
- SODIUM BENZOATE
- SODIUM PHOSPHATE
- SODIUM PHOSPHATE DIBASIC DIHYDRATE
- SACCHARIN SODIUM
- SORBITOL
- WATER
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67933-0016 | 67933-0016-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PerCara Kids Bubble Gum | SODIUM FLUORIDE | LEC Custom Products, Inc. | be3a7272-acfb-7d14-e053-2995a90a9420 | 2024-01-01 | Warnings | 67933-0016-1 67933-0016 67933001601 0eb3968a-ead0-c8c9-e063-6394a90a06e5 be3a7272-acfb-7d14-e053-2995a90a9420 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.