OTC Medication Information: K2 Cold Therapy

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.

Menthol 10%

Purpose

Topical Analgesic

Uses

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

  • ARTHRITIS
  • SIMPLE BACKACHE
  • MUSCLE STRAINS
  • SPRAINS

Warnings

For external use only.

When using this product

  • 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 and ask a doctor if

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

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

  • 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.

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
(click image for full-size original)

K2 COLD THERAPY
menthol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54633-414
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CAMPHOR (NATURAL)
EUCALYPTUS GLOBULUS LEAF
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
POLYSORBATE 80
ROSMARINUS OFFICINALIS WHOLE
ALCOHOL
SIMMONDSIA CHINENSIS WHOLE
SORBITAN SESQUIOLEATE
STEARETH-2
STEARETH-20
UREA
VITIS VINIFERA SEED
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54633-414-03 88.72 mL in 1 BOTTLE, WITH APPLICATOR None
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)

Revised: 01/2018 The Podiatree Co

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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