K2 COLD THERAPY- menthol liquid

K2 Cold Therapy by

Drug Labeling and Warnings

K2 Cold Therapy by is a Otc medication manufactured, distributed, or labeled by The Podiatree Co, EMS Contract Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingrdient:

Menthol 10%

PURPOSE

PURPOSE

TOPICAL ANALGESIC

INDICATIONS & USAGE

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

• ARTHRITIS
• SIMPLE BACKACHE
• MUSCLE STRAINS
• SPRAINS

WARNINGS

For external use only.

Flammable; Keep away from fire, sparks and heated surfaces

WHEN USING

• Use only as directed
• Do not bandage tighlty or use with a heating pad
• Avoid contact with eyes and mucous membranes
• Do not apply to wounds or damaged, broken, or irritated skin.

STOP USE

• Condition worsens
• Redness is present
• Irritation develops
• Symptoms persist for more than 7 days or clear up and reoccur within a few days

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• Adults and children 12 years of age and older: Apply a thin layer over the affected area not more than 3 to 4 times daily.
• Children 12 years of age or younger: Consult a doctor.
• Close cap tightly after use.

STORAGE AND HANDLING

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

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

1.855.763.8733 or visit us at www.thepodiatreecompany.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

K2 COLD THERAPY 
menthol liquid

Product 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)