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NDC 51009-0837-52 Toms Whole Care Mouthwash Fresh Mint 1 mg/10mL Details
Toms Whole Care Mouthwash Fresh Mint 1 mg/10mL
Toms Whole Care Mouthwash Fresh Mint is a DENTAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by Tom's of Maine, 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: 51009-0837-52Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 51009-0837 |
|---|---|
| Product ID | 51009-837_65501f6e-06b7-44a3-ab5a-b663d740afb7 |
| 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 | Toms Whole Care Mouthwash Fresh Mint |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sodium Fluoride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | RINSE |
| Route | DENTAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/10mL |
| Substance Name | SODIUM FLUORIDE |
| Labeler Name | Tom's of Maine, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51009-0837-52 (51009083752)
| NDC Package Code | 51009-837-52 |
|---|---|
| Billing NDC | 51009083752 |
| Package | 473 mL in 1 BOTTLE (51009-837-52) |
| Marketing Start Date | 2017-12-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6875f5c1-853c-43da-8226-c09a5518f9bb Details
Warnings
Directions
Adults and children 6 years of age and older:
- use twice a day after brushing your teeth with a toothpaste
- vigorously swish 10 milliliters of rinse 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 (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
Children under 6 years of age: consult a dentist or doctor
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Certified
B®
Corporation
NEW
LOOK
THE ORIGINAL
Tom's
OF MAINE
NATURAL • WITH FLUORIDE
WHOLE CARE®
anticavity mouthwash
6 • BENEFITS FOR HEALTHY TEETH
6 BENEFITS
- fights cavities
- freshens breath
- restores minerals
- strengthens enamel
- cleans between teeth
- alcohol-free
FRESH MINT
16 FL OZ (473 mL)
IMPORTANT: Read
directions for proper use
PS0022908
INGREDIENTS AND APPEARANCE
| TOMS WHOLE CARE MOUTHWASH FRESH MINT
sodium fluoride rinse |
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| Labeler - Tom's of Maine, Inc. (052764354) |