FDA Label for Periomed
View Indications, Usage & Precautions
Periomed Product Label
The following document was submitted to the FDA by the labeler of this product Solventum Us Opco Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Active Ingredient
Stannous fluoride 0.63% w/w (0.19% w/v flouride 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 doctor if sensitivity persists or worsens.
- Sensitive teeth may indicate a serious problem that may need prompt care.
Otc - Keep Out Of Reach Of Children
- 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 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
- consult a dentist or doctor
children under 6 years of age:
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
Inactive Ingredients
flavor, glycerin, methyl paraben, propyl paraben, sodium saccharin
Questions Or Comments?
1-800-634-2249
Principal Display Panel – Box Label
NDC 48878-3315-0
Mint
3M ESPE
PerioMed™
0.63% Stannous
Fluoride Concentrate
Antimicrobial
Oral Rinse
Non-Alcohol
Formula
IMPORTANT: Read
directions carefully
before using.
Contents:
1 Bottle
NET WT. 10 oz (283.5g)
NDC 48878-3315-2
Mint
3M ESPE
PerioMed™
0.63% Stannous
Fluoride Concentrate
Antimicrobial
Oral Rinse
Non-Alcohol
Formula
IMPORTANT: Read
directions carefully
before using.
Contents:
1 Bottle
NET WT. 2.75 oz (78g)
NDC 48878-3317-0
Tropical Fruit
3M ESPE
PerioMed™
0.63% Stannous
Fluoride Concentrate
Antimicrobial
Oral Rinse
Non-Alcohol
Formula
IMPORTANT: Read
directions carefully
before using.
Contents:
1 Bottle
NET WT. 10 oz (283.5g)
* Please review the disclaimer below.