FDA Label for Family Wellness Ultra Mouthwash
View Indications, Usage & Precautions
Family Wellness Ultra Mouthwash Product Label
The following document was submitted to the FDA by the labeler of this product Family Dollar Services Inc.. 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
DISTRIBUTED BY: Midwood Brands, LLC
500 Volvo Parkway, Chesapeake, VA 23320
Made in Canada
* This product is not manufactured or distributed by Johnson & Johnson, distributor of Listerine®.
Otc - Active Ingredient
Active ingredients
Eucalyptol 0.092%, Menthol 0.042%
Methyl salicylate 0.060%, Thymol 0.064%
Otc - Purpose
Purpose
Antigingivitis, Antiplaque
Antigingivitis, Antiplaque
Indications & Usage
Use helps control plaque that leads to gingivitis
Warnings
Warnings
Otc - Do Not Use
Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodonititis, a serious form of gum disease.
Otc - Stop Use
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
adults and children 12 years of age and older | vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow |
children 6 years to under 12 years of age | supervise use |
children under 6 years | do not use |
- This rinse is not intended to replace brushing or flossing
Storage And Handling
Other information cold weather may cloud this product. Its antiseptic properties are not affected . Store at room temperature (59° - 86°F)
Inactive Ingredient
Inactive ingredients water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, blue 1.
Package Label.Principal Display Panel
COMPARE TO LISTERINE® ULTRACLEAN*
FAMILY wellness™
ULTRA
MOUTHWASH
ANTISEPTIC MOUTHRINSE
Helps Kill Germs that Cause Bad Breath, Plaque and Gingivitis Gum Disease
3.8 FL OZ (1000 mL)
* Please review the disclaimer below.