Package Insert and Label Information: PerioMed
PERIOMED- stannous fluoride rinse
3M ESPE Dental Products
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Facts
Active ingredient
Stannous fluoride 0.63% concentrate (0.12% w/v fluoride ion)
Purpose
anticavity, antigingivitis, antihypersensitivity, mouthrinse
Uses
- aids in the prevention of childhood dental decay
- helps prevent gingivitis
- helps control plaque bacteria
- builds increasing protection against painful tooth sensitivity
Warnings
- when using this product do not use for sensitivity longer than four weeks unless recommended by a dentist
- stop use and ask a dentist if sensitivity persists or worsens
- sensitive teeth may indicate a serious problem that may need prompt care
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, seek medical attention or contact a Poison Control Center immediately.
Directions
adults and children 6 years of age and older:
- do not use before mixing with water
- use once daily after brushing your teeth with a toothpaste or as directed by your dentist
- remove cap and replace with pump
- rotate spout counter clockwise to extend
- depress pump until medicine comes to the tip of the pump
- make 2 complete pump depressions into cup provided (1/8 oz)
- add tap water to line (1 oz) on cup
- mix using bristle end of toothbrush
- 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 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
Other information
- 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
- For Professional Office Use Only
- This product is not intended for home or unsupervised consumer use.
Inactive ingredients
glycerin, flavor
Questions or comments?
1-800-634-2249
Principal Display Panel – Box Label
Mint
NDC 48878-3315-0
3M ESPE
PerioMed™
0.63% Stannous
Fluoride Concentrate
Antimicrobial
Oral Rinse
Alcohol Free
IMPORTANT: Read
directions thoroughly.
OMNI
Contents:
1 Bottle
NET WT. 10 oz (283.5g)
Principal Display Panel – Box Label
Cinnamon
NDC 48878-3316-0
3M ESPE
PerioMed™
0.63% Stannous
Fluoride Concentrate
Antimicrobial
Oral Rinse
Alcohol Free
IMPORTANT: Read
directions thoroughly.
OMNI
Contents:
1 Bottle
NET WT. 10 oz (283.5g)
Principal Display Panel – Box Label
Tropical Fruit
NDC 48878-3317-0
3M ESPE
PerioMed™
0.63% Stannous
Fluoride Concentrate
Antimicrobial
Oral Rinse
Alcohol Free
IMPORTANT: Read
directions thoroughly.
OMNI
Contents:
1 Bottle
NET WT. 10 oz (283.5g)
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| Labeler — 3M ESPE Dental Products (799975909) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| 3M ESPE Dental Products | 799975909 | MANUFACTURE | |
Revised: 02/2009 3M ESPE Dental Products
