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 ingredient:

Menthol 10%

Purpose

Topical Analgesic

Uses

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

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.

Directions

Other information

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

Inactive Ingredients

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 or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisf ication. If you are not completely satisfied, please contact us for a full refund.

label

K2 COLD THERAPY 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-414
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:54633-414-0388.72 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/06/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/06/2014
Labeler - The Podiatree Co (078656000)

Revised: 1/2018
Document Id: 625ba6c8-a04b-12c9-e053-2991aa0aad86
Set id: 60dce1ad-125e-396d-e053-2a91aa0a670f
Version: 3
Effective Time: 20180109
 
The Podiatree Co