Poison Ivy And Oak Relief
FDA Label NDC 57955-5116

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 Poison Ivy And Oak Relief (NDC 57955-5116). 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, inactive ingredient, warnings, otc - keep out of reach of children, dosage & administration, other safety information, 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: Anacardium occidentale, Clematis erecta, Croton tiglium, Cypripedium pubescens, Echinacea purpurea, Erechtites hieracifolia, Graphites, Grindelia, Histaminum hydrochloricum, Mezereum, Rhus toxicodendron, Urtica urens. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.​

Indications & Usage

Uses for temporary relief of skin irritations related to poison ivy, poison oak, poison sumac, detergents, cosmetics, or other irritants: •minor swelling •itching •burning sensation •rashes •skin eruptions with oozing.

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

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Warnings

Warnings

  • Stop use and ask a doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children ages 2-12: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

Other Safety Information

Tamper resistant for your protection. Use only if seal is intact. Keep carton for complete drug facts and product information.

Otc - Purpose

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients                                           Purpose †

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

Anacardium occidentale...............................intense itching, swelling

Clematis erecta...........................................red, burning, scaly skin

Croton tiglium........................................severe itching and stinging

Cypripedium pubescens............................................intense itching

Echinacea purpurea..................................................skin irritations

Erechtites hieracifolia............................................red, swollen skin

Graphites.............................................................oozing eruptions

Grindelia................................................severe burning and itching

Histaminum hydrochloricum..................................red, itchy papules

Mezereum.................................................eruption with oozing pus

Rhus toxicodendron........................................intense itching of skin

Urtica urens....................................skin eruptions with burning heat

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

* Please review the disclaimer below.