Wart Remover
FDA Label NDC 57955-0818

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 Wart Remover (NDC 57955-0818). 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

___________________________________________________________________________________________________________________

HPUS active ingredients: Antimonium crudum, Causticum, Dulcamara, Kali muriaticum, Nitricum acidum, Sabina, Staphysagria, Sulphur, Thuja occidentalis.  Equal volumes of each ingredient in 10X, 30X, and LM1 potencies. “HPUS”indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Indications & Usage

Uses​ for symptomatic treatment of smooth or rough warts and dry, itching or unhealthy skin.

†as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Warnings

Warnings

  • Stop use and ask your 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, chamomile oil, clove oil, lemon oil, oregano oil, tea tree oil.

Otc - Purpose

Drug Facts

___________________________________________________________________________________________________________________

HPUS* active ingredients                                            Purpose†

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

Antimonium crudum............................................vesicles, warts

Causticum........................................................warts on fingers

Dulcamara...........................................................warts on face

Kali muriaticum..................................................vesicles on skin

Nitricum acidum.....................................................jagged warts

Sabina........................................................................fig-warts

Staphysagria..........................................................dryness, itch

Sulphur...............................................................unhealthy skin

Thuja occidentalis.........................................................fig-warts

“HPUS”indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

* Please review the disclaimer below.