FAMILY WELLNESS ANTICAVITY FRESH MINT- sodium fluoride mouthwash

Family Wellness by

Drug Labeling and Warnings

Family Wellness by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient
Sodium fluoride 0.0221%

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Useaids in the prevention of dental cavities

WARNINGS

Warnings

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: use twice daily after brushing your teeth with toothpaste; vigorously swish 10 mL (2 teaspoonfuls) between teeth for 1 minute then spit out; do not swallow
• children under 12 years of age: consult a dentist or doctor

STORAGE AND HANDLING

Other information cold weather may cloud this product. Its antiseptic properties are not affected . Store at room temperature (59° - 77°F)

INACTIVE INGREDIENT

Inactive ingredients water, sorbitol, alcohol 21.6%, flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose and/or sodium saccharin, dibasic sodium phosphate, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6.

SPL UNCLASSIFIED SECTION

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®.

PRINCIPAL DISPLAY PANEL

COMPARE TO LISTERINE® TOTAL CARE*

FAMILY wellness™

TOTAL HEALTH

FRESH MINT

MOUTHWASH

6 IN 1 FORMULA

• Helps Prevent Cavities
• Kills Germs that Cause Bad Breath
• Helps Keep Mouth Feeling Clean
• Freshens Breath
• Helps Strengthen Enamel
• Helps Strengthen Teeth

33.8 FL OZ (1000 mL)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS  ANTICAVITY FRESH MINT
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-233
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SORBITOL (UNII: 506T60A25R)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-233-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/20/2019

Labeler - Family Dollar Services Inc. (024472631)