K2 Cold Therapy
FDA Label NDC 54633-201

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Podiatree Co for the product K2 Cold Therapy (NDC 54633-201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingrdient:

Menthol 10%

Otc - 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

Otc - 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.

Otc - 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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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)

Otc - Questions

1.855.763.8733 or visit us at www.thepodiatreecompany.com

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