SMART SENSE ALCOHOL FREE- cetylpyridinium chloride liquid

SMART SENSE by

Drug Labeling and Warnings

SMART SENSE by is a Otc medication manufactured, distributed, or labeled by KMART CORPORATION, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

CETYLPYRIDINIUM CHLORIDE 0.07%

PURPOSE

ANTIPLAQUE/ANTIGINGIVITIS

USES

HELPS REDUCE AND PREVENT PLAQUE AND GINGIVITIS. HELPS CONTROL PLAQUE BACTERIA THAT CONTRIBUTE TO THE DEVELOPMENT OF GINGIVITIS AND BLEEDING GUMS.

WARNINGS

ASK A DENTIST IF SYMPTOMS PERSIST OR CONDITION WORSENS AFTER REGULAR USE.

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.

IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222).

DIRECTIONS

USE AFTER YOUR NORMAL BRUSHING AND FLOSSING ROUTINE; RINSE TOOTHPASTE FROM MOUTH PRIOR TO USE. ADULTA AND CHILDREN 6 YEARS AND OLDER: RINSE FOR 30 SECONDS WITH 20 ML (4 TEASPOONFULS) TWICE A DAY. DO NOT SWALLOW. CHILDREN 6 YEARS TO UNDER 12 YEARS OF AGE: SUPERVISE USE. CHILDREN UNDER 6 YEARS OF AGE: DO NOT USE.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS:

WATER (AQUA), GLYCERIN, POLOXAMER 407, FLAVOR, SODIUM SACCHARIN, METHYLPARABEN, SUCRALOSE, PROPYLPARABEN, BLUE 1 (CI 42090).

QUESTIONS OR COMMENTS?

1-800-842-7886

LABEL COPY

INGREDIENTS AND APPEARANCE

SMART SENSE  ALCOHOL FREE
cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-553
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-553-34	1000 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/09/2013

Labeler - KMART CORPORATION (008965873)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(49738-553)