Your browser does not support JavaScript! SMART SENSE ICEBERG BLUE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [KMART CORPORATION]
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RxNorm Names

SMART SENSE ICEBERG BLUE (eucalyptol, menthol, methyl salicylate, thymol) liquid
[Kmart Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 accidently swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Directions

Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce) or 4 teaspoons ful) mornings 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, Zinc Chloride, Sodium Benzoate, Sucralose, Sodium Saccharin, Blue 1 (CI 42090)

Questions or comments?

1-800-842-7886

Label Copy

Image of the Label

SMART SENSE  ICEBERG BLUE
eucalyptol, menthol, methyl salicylate, thymol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49738-551
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.6 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
BENZOIC ACID 
ZINC CHLORIDE 
SODIUM BENZOATE 
SUCRALOSE 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-551-341000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/22/2013
Labeler - Kmart Corporation (008965873)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture(49738-551)

Revised: 4/2013
 
Kmart Corporation

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