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SMART SENSE

Kmart Corporation
APOLLO HEALTH AND BEAUTY CARE

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT

SODIUM FLUORIDE 0.02% (0.01% 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 12 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 12 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, ALCOHOL (21.6%), POLOXAMER 407, SODIUM LAURYL SULFATE, EUCALYPTOL, FLAVOR, METHYL SALICYLATE, THYMOL, PHOSPHORIC ACID, SUCRALOSE, MENTHOL, DISODIUM PHOSPHATE, RED 40 (CI 16035), BLUE 1 (CI 42090). 

QUESTIONS OR COMMENTS?

1-800-842-7886

LABEL COPY

SMART SENSE

SMART SENSE

SODIUM FLUORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49738-552
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.2 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
ALCOHOL
POLOXAMER 407
SODIUM LAURYL SULFATE
EUCALYPTOL
methyl salicylate
THYMOL
phosphoric acid
Sucralose
MENTHOL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C RED NO. 40
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49738-552-34 1000 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2013-05-09


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