- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Aloe Barbadensis Leaf Juice, Camphor, Eucalyptus Globulus Leaf Oil, FD&C Blue #1, FD&C Yellow #5, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Oil, SD 40 Alcohol (5%) Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Sesquioleate, Steareth 2, Steareth 20, Urea, Vitis Vinifera (Grape) Seed Extract, Water (Purified)
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
K2 COLD THERAPY
menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54633-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMPHOR (NATURAL) (UNII: N20HL7Q941) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M) ALCOHOL (UNII: 3K9958V90M) SIMMONDSIA CHINENSIS WHOLE (UNII: DFM16KFA82) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) STEARETH-2 (UNII: V56DFE46J5) STEARETH-20 (UNII: L0Q8IK9E08) UREA (UNII: 8W8T17847W) VITIS VINIFERA SEED (UNII: C34U15ICXA) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54633-201-13 88.72 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/06/2014 Labeler - The Podiatree Co (078656000) Establishment Name Address ID/FEI Business Operations EMS Contract Packaging 048602791 manufacture(54633-201)