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NDC 67933-0016-01 PerCara Kids Bubble Gum 0.05 g/100mL Details
PerCara Kids Bubble Gum 0.05 g/100mL
PerCara Kids Bubble Gum is a ORAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by LEC Custom Products, Inc.. The primary component is SODIUM FLUORIDE.
MedlinePlus Drug Summary
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 67933-0016-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 67933-0016 |
|---|---|
| Product ID | 67933-0016_be3a7272-acfc-7d14-e053-2995a90a9420 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | PerCara Kids Bubble Gum |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sodium fluoride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | RINSE |
| Route | ORAL |
| Active Ingredient Strength | 0.05 |
| Active Ingredient Units | g/100mL |
| Substance Name | SODIUM FLUORIDE |
| Labeler Name | LEC Custom Products, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 67933-0016-01 (67933001601)
| NDC Package Code | 67933-0016-1 |
|---|---|
| Billing NDC | 67933001601 |
| Package | 532 mL in 1 BOTTLE, PLASTIC (67933-0016-1) |
| Marketing Start Date | 2021-03-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL be3a7272-acfb-7d14-e053-2995a90a9420 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| PERCARA KIDS BUBBLE GUM
sodium fluoride rinse |
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| Labeler - LEC Custom Products, Inc. (204065726) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LEC Custom Products, Inc | 204064757 | manufacture(67933-0016) | |
Revised: 3/2021
Document Id: be3a7272-acfc-7d14-e053-2995a90a9420
Set id: be3a7272-acfb-7d14-e053-2995a90a9420
Version: 1
Effective Time: 20210323