FAMILY WELLNESS TOTAL HEALTH- cetylpyridinium chloride rinse

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
Cetylpyridinium chloride 0.07%

PURPOSE

Purpose

Antigingivitis, Antiplaque

INDICATIONS & USAGE

Usehelps control plaque that leads to gingivitis

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 6 years of age and older: use twice a day after brushing your teeth with toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) of 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

INACTIVE INGREDIENT

Inactive ingredients water, glycerin, flavor, poloxamer 407, sodium saccharin and/or sucralose, citric acid, blue 1.

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 Proctor and Gamble, distributor of Crest®.

PRINCIPAL DISPLAY PANEL

COMPARE TO CREST® PRO HEALTH*

FAMILY wellness™

ALCOHOL FREE

TOTAL HEALTH

MOUTH RINSE

MULTI-ACTION ANTISEPTIC

• Kills Germs that Cause Bad Breath, Plaque and Gingivitis
• Freshens Breath
• Helps Keep Mouth Feeling Clean
• No Burn of Alcohol

33.8 FL OZ (1000 mL)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS  TOTAL HEALTH
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-234
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.07 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-234-86	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 not final	part356	06/20/2019

Labeler - Family Dollar Services Inc. (024472631)