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NDC 48878-3315-02 PerioMed 1.53 mg/g Details
PerioMed 1.53 mg/g
PerioMed is a ORAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by 3M ESPE Dental Products. The primary component is STANNOUS 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: 48878-3315-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 48878-3315 |
|---|---|
| Product ID | 48878-3315_020022a2-f258-49c2-b361-c7434ad6b8b4 |
| Associated GPIs | 88402030001320 |
| GCN Sequence Number | 059921 |
| GCN Sequence Number Description | stannous fluoride SOLN(GRAM) 0.63% DENTAL |
| HIC3 | D2A |
| HIC3 Description | FLUORIDE PREPARATIONS |
| GCN | 25853 |
| HICL Sequence Number | 001128 |
| HICL Sequence Number Description | STANNOUS FLUORIDE |
| Brand/Generic | Brand |
| Proprietary Name | PerioMed |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | stannous fluoride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | RINSE |
| Route | ORAL |
| Active Ingredient Strength | 1.53 |
| Active Ingredient Units | mg/g |
| Substance Name | STANNOUS FLUORIDE |
| Labeler Name | 3M ESPE Dental Products |
| 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 48878-3315-02 (48878331502)
| NDC Package Code | 48878-3315-2 |
|---|---|
| Billing NDC | 48878331502 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (48878-3315-2) / 85 g in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2016-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7f79eb00-86df-4284-b415-47f45e4849da Details
Uses
Warnings
Directions
adults and children 6 years of age and older:
- do not use before mixing with water
- use immediately after preparing the rinse
- use as directed by a dental professional
- use once a day after brushing your teeth with a toothpaste or as directed by your dentist
- remove cap and seal and replace with pump
- rotate spout counter clockwise to extend
- depress pump until medicine comes to the tip of the pump
- put 1/8 oz. (approx. 2 pump strokes) of concentrated PerioMed Rinse into the provided mixing vial
- add water to 1 oz. line on mixing vial
- tightly snap on the cap and shake well
- vigorously swish 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 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
Other information
- For professional use only
- products containing stannous fluoride may produce surface staining of the teeth
- adequate toothbrushing may prevent these stains which are not harmful and may be removed by your dentist
- see your dentist regularly
- this product is not intended for home or unsupervised consumer use
- for your protection, do not use if seal under the cap is broken or missing
Principal Display Panel – Box Label (Mint – 283.5 g)
Principal Display Panel – Box Label (Mint – 78 g)
Principal Display Panel – Box Label (Tropical Fruit – 283.5 g)
INGREDIENTS AND APPEARANCE
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stannous fluoride rinse |
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| Labeler - 3M ESPE Dental Products (801390852) |
Revised: 7/2022
Document Id: 020022a2-f258-49c2-b361-c7434ad6b8b4
Set id: 7f79eb00-86df-4284-b415-47f45e4849da
Version: 7
Effective Time: 20220725