Poison ivy - Prescription Drug Labeling

Active ingredient

A list of the active, medicinal ingredients in the drug product.

OTC - ACTIVE INGREDIENT SECTION Equal parts of Echinacea 6x, Rumex crispus 6x, Taraxacum officinale 6x, Urtica urens 6x, Aconitum napellus 15x, Anacardium occidentale 15x, Apis mellifica 15x, Bryonia 15x, Cantharis 15x, Croton tiglium 15x, Graphites 15x, Grindelia 15x, Mezereum 15x, Nux vomica 15x, Ranunculus bulbosus 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sulphur 15x, Xerophyllum asphodeloides 30x.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.

DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.

INACTIVE INGREDIENT SECTION Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.

INDICATIONS & USAGE SECTION Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

Purpose

Information about the drug product’s indications for use.

OTC - PURPOSE SECTION Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

Spl product data elements

Usually a list of ingredients in a drug product.

Poison Ivy Xerophyllum asphodeloides, Aconitum nap., Anacardium orientale, Apis mel., Bryonia, Cantharis, Croton, Graphites, Grindelia, Mezereum, Nux vom., Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp.,Taraxacum, Urtica ur. ALCOHOL XEROPHYLLUM ASPHODELOIDES XEROPHYLLUM ASPHODELOIDES ACONITUM NAPELLUS ACONITUM NAPELLUS SEMECARPUS ANACARDIUM JUICE SEMECARPUS ANACARDIUM JUICE APIS MELLIFERA APIS MELLIFERA BRYONIA ALBA ROOT BRYONIA ALBA ROOT LYTTA VESICATORIA LYTTA VESICATORIA CROTON TIGLIUM SEED CROTON TIGLIUM SEED GRAPHITE GRAPHITE GRINDELIA HIRSUTULA FLOWERING TOP GRINDELIA HIRSUTULA FLOWERING TOP DAPHNE MEZEREUM BARK DAPHNE MEZEREUM BARK STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED RANUNCULUS BULBOSUS RANUNCULUS BULBOSUS TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SMILAX ORNATA ROOT SMILAX ORNATA ROOT SULFUR SULFUR ECHINACEA, UNSPECIFIED ECHINACEA, UNSPECIFIED RUMEX CRISPUS ROOT RUMEX CRISPUS ROOT TARAXACUM OFFICINALE TARAXACUM OFFICINALE URTICA URENS URTICA URENS WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.

PACKAGE LABEL package label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.

QUESTIONS SECTION newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Pregnancy or breast feeding

Pregnancy or Breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding, ask a doctor before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.

WARNINGS SECTION WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.