FAMILY WELLNESS ORIGINAL AMBER- eucalyptol, menthol, methyl salicylate, thymol 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 ingredients
Eucalyptol 0.092%, Menthol 0.042%

Methyl Salicylate 0.060%, Thymol 0.064%

PURPOSE

Purpose

Antigingivitis, Antiplaque

Antigingivitis, Antiplaque

INDICATIONS & USAGE

Usehelps control plaque that leads to gingivitis

WARNINGS

Warnings

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 periodontitis, a serious form of gum disease.

Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks

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 OS or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

– children under 12 years of age: consult a dentist or doctor

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° - 77°F)

INACTIVE INGREDIENT

Inactive ingredients water, alcohol 21.6%, benzoic acid, poloxamer 407, sodium benzoate, caramel.

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® ORIGINAL*

FAMILY wellness™

ORIGINAL AMBER

MOUTHWASH

DEEP CLEAN FOR FRESHER BREATH

Helps Kill Germs that Cause Bad Breath, Plaque and Gingivitis Gum Disease

33.8 FL OZ (1000 mL)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS  ORIGINAL AMBER
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-232
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.092 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.042 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.06 g  in 100 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.064 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-232-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/20/2019
2	NDC: 55319-232-23	250 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 not final	part356	06/20/2019

Labeler - Family Dollar Services Inc. (024472631)