SMART SENSE ALCOHOL FREE- sodium fluoride liquid 
KMART CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENT

SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)

PURPOSE

ANTICAVITY

USES

AIDS IN THE PREVENTION OF DENTAL CAVITIES.

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 IMMEDIATELY (1-800-222-1222).

KEEP OUT OF REACH OF CHILDREN.

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

DIRECTIONS

ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER: USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH A TOOTHPASTE. VIGOROUSLY SWISH 10 ML 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. SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER 6 YEARS OF AGE: CONSULT A DENTIST OR DOCTOR.

OTHER INFORMATION

STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F). COLD WEATHER MAY CLOUD THIS PRODUCT.

INACTIVE INGREDIENTS:

WATER (AQUA), SORBITOL, PROPYLENE GLYCOL, POLYSORBATE 20, FLAVOR, SODIUM PHOSPHATE, POLOXAMER 407, SODIUM BENZOATE, CALCIUM DISODIUM EDTA, POTASSIUM SORBATE, DISODIUM PHOSPHATE, SODIUM SACCHARIN, CETYLPYRIDINIUM CHLORIDE, MENTHOL, METHYL SALICYLATE, GREEN 3 (CI 42053), YELLOW 5 (CI 19140).

QUESTIONS OR COMMENTS?

1-800-842-7886

LABEL COPY

IMAGE OF THE LABEL

SMART SENSE  ALCOHOL FREE
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-554
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-554-18532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/09/2013
Labeler - KMART CORPORATION (008965873)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(49738-554)

Revised: 5/2013
Document Id: e99e0f9f-b4b8-478f-a21c-79cd724c02af
Set id: c9375caf-f75f-4c3d-b2cf-55e4bb6bd8fc
Version: 1
Effective Time: 20130509
 
KMART CORPORATION