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NDC 51009-0840-52 Toms Childrens Anticavity Mouthwash Silly Strawberry 2 mg/10mL Details
Toms Childrens Anticavity Mouthwash Silly Strawberry 2 mg/10mL
Toms Childrens Anticavity Mouthwash Silly Strawberry 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: 51009-0840-52Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 51009-0840 |
|---|---|
| Product ID | 51009-840_2384ce1c-33a5-41fd-aa4f-4fe617bdea33 |
| 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 Childrens Anticavity Mouthwash Silly Strawberry |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium fluoride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | RINSE |
| Route | DENTAL |
| Active Ingredient Strength | 2 |
| 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 51009-0840-52 (51009084052)
| NDC Package Code | 51009-840-52 |
|---|---|
| Billing NDC | 51009084052 |
| Package | 473 mL in 1 BOTTLE (51009-840-52) |
| Marketing Start Date | 2018-12-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 998c6f35-20f4-4cb8-bc48-6aa39e61481a 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
water, glycerin, Aloe barbadensis leaf juice1, xylitol, sodium phosphate, propanediol, benzoic acid, natural flavor, phosphoric acid, menthol, Fragaria ananassa (Strawberry) fruit juice, Ananas sativus (Pineapple) fruit juice, Citrus aurantium dulcis (Orange) juice, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Rebaudioside A
- 1
- organic
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
INGREDIENTS AND APPEARANCE
| TOMS CHILDRENS ANTICAVITY MOUTHWASH SILLY STRAWBERRY
sodium fluoride rinse |
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| Labeler - Tom's of Maine, Inc. (052764354) |