SMART SENSE ICEBERG BLUE- eucalyptol, menthol, methyl salicylate and thymol 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.

----------

DRUG FACTS

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49738-551
Route of Administration ORAL DEA Schedule     
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 0.6 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)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49738-551-34 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 04/22/2013
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(49738-551)

Revised: 4/2013
Document Id: 7a1fcc3f-44e8-4901-8cbe-0c512fcde547
Set id: 1c7d2a93-6903-4320-bc65-97c510688600
Version: 1
Effective Time: 20130422
 
Kmart Corporation