Mole Remover
FDA Label NDC 57955-0815

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Mole Remover (NDC 57955-0815). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

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HPUS active ingredients: Carbo vegetabilis, Graphites, Lycopodium clavatum, Phytolacca decandra, Thuja occidentalis.

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Indications & Usage

Uses for symptomatic treatment of moles, birthmarks, brown spots, or freckles.

Warnings

Warnings

  • Stop use and ask a doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.
  • Keep out of reach of children.
  • For external use only.
  • Avoid using near eyes or mouth.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
  • Some individuals may be sensitive to essential oils. If irritation or reaction occurs, discontinue use.
  • May stain clothing.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

Directions

  • Shake before using.
  • Adults and children (6-12): apply 3 times daily to affected area.
  • It will dry and flake away over a period of 3-6 weeks.

Other Safety Information

Other information:

  • Intended to complement, not replace, standard medical care. 
  • Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredient

Inactive Ingredients: Alcohol, castor oil, cedar leaf oil, frankincense oil, lavender oil, oregano oil, tea tree oil.

Otc - Purpose

Drug Facts

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HPUS active ingredients                                               Purpose

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Carbo vegetabilis........................................................birthmarks

Graphites...................................................................moles

Lycopodium clavatum..................................................brown spots

Phytolacca decandra....................................................moles

Thuja occidentalis........................................................freckles

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