Compound W Total Care Wart And Skin Kit
FDA Label NDC 49354-130

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hk Kolmar Canada, Inc for the product Compound W Total Care Wart And Skin Kit (NDC 49354-130). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredient

Salicylic acid 17% w/w

Purpose

Wart remover

Uses

  • for the removal of common and plantar warts
  • the common wart is easily recognized by the rough “cauliflower-like” appearance on the surface.
  • the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and interruption of the footprint pattern

Warnings

For external use only. Flammable. Keep away from fire and flame.

Do Not Use

  • on irritated skin or on any area that is infected or reddened
  • on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes.
  • if you have diabetes or poor blood circulation.

When Using This Product

  • avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes.
  • avoid inhaling vapors
  • cap tightly and store at room temperature away from heat

Stop Use And Ask A Doctor If

discomfort persists.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • wash affected area
  • may soak wart in warm water for 5 minutes
  • dry area thoroughly
  • by squeezing tube gently, apply one drop at a time to sufficiently cover each wart
  • let dry
  • repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

Other Information

  • store at room temperature
  • avoid excessive heat 37°C (99°F)
  • skin discoloration may accur during or after use
  • wipe the tip of the tube with a paper towel between uses

Inactive Ingredients

alcohol, camphor, castor oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropanol, nitrocellulose, polysorbate 80, water

Questions?

1-800-443-4908  CompoundW.com

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