Label: SMART SENSE ICEBERG BLUE- eucalyptol, menthol, methyl salicylate and thymol liquid
- NDC Code(s): 49738-551-34
- Packager: Kmart Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENTS
Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%Close
To help reduce and prevent plaque and gingivitisClose
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)
Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce) or 4 teaspoons ful) mornings and night. Do not swallowClose
- OTHER INFORMATION
Store at room temperature. Cold weather may cloud this product. Its antiseptic properties are not affected.Close
- 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)Close
- Questions or comments?
- Label Copy
- INGREDIENTS AND APPEARANCE
SMART SENSE ICEBERG BLUE
eucalyptol, menthol, methyl salicylate, thymol liquid
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49738-551 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg in 1 mL MENTHOL (MENTHOL) MENTHOL 0.42 mg in 1 mL METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.6 mg in 1 mL THYMOL (THYMOL) THYMOL 0.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID ZINC CHLORIDE SODIUM BENZOATE SUCRALOSE SACCHARIN SODIUM FD&C BLUE NO. 1 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)