SMART SENSE BLUE MINT- eucalyptol, menthol, methyl salicylate, thymol 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

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Purpose

Antiplaque/Antigingivitis

Uses

to help reduce and prevent plaque and gingivitis

Warnings

Do not use for children under 12 years of age

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
• Do not swallow

Other information

• Store at room temperature
• Cold weather may cloud this product. Its antiseptic properties are not affected

Inactive ingredients

Water (Aqua), Alcohol (21.6%), Sorbitol Solution, Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Green 3 (CI 42053).

Questions or comments?

1-800-842-7886

Label Copy

INGREDIENTS AND APPEARANCE

SMART SENSE  BLUE MINT
eucalyptol, menthol, methyl salicylate, thymol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-557
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-557-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/26/2015

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(49738-557)