K2 COLD THERAPY- menthol liquid 
The Podiatree Co

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.

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Active ingrdient:

Menthol 10%

PURPOSE

TOPICAL ANALGESIC

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

For external use only.

Flammable; Keep away from fire, sparks and heated surfaces

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Store at controlled room temperature. Do not shake bottle with cap removed.

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)

1.855.763.8733 or visit us at www.thepodiatreecompany.com

k2 Cold Therapy

K2 COLD THERAPY 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54633-201-1388.72 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/06/2014
Labeler - The Podiatree Co (078656000)
Establishment
NameAddressID/FEIBusiness Operations
EMS Contract Packaging048602791manufacture(54633-201)

Revised: 4/2014
Document Id: c0cea7f6-24bb-4efc-9e67-37835acf6b03
Set id: 6ff293e6-951b-4b8d-8f62-9d7985f340b7
Version: 1
Effective Time: 20140418
 
The Podiatree Co