Poison Ivy: Homeopathic Product Information

POISON IVY- xerophyllum asphodeloides, aconitum napellus, semecarpus anacardium juice, apis mellifera, bryonia alba root, lytta vesicatoria, croton tiglium seed, graphite, grindelia hirsutula flowering top, daphne mezereum bark, strychnos nux-vomica seed, ranunculus bulbosus, toxicodendron pubescens leaf, smilax ornata root, sulfur, echinacea, unspecified, rumex crispus root, taraxacum officinale and urtica urens liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

INDICATIONS & USAGE SECTION

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

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.

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.

OTC — PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 — Conyers, GA 30013

OTC — PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

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.

OTC — KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

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. liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4801 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XEROPHYLLUM ASPHODELOIDES (XEROPHYLLUM ASPHODELOIDES) XEROPHYLLUM ASPHODELOIDES 30 [hp_X] in 1 mL ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 15 [hp_X] in 1 mL SEMECARPUS ANACARDIUM JUICE (SEMECARPUS ANACARDIUM JUICE) SEMECARPUS ANACARDIUM JUICE 15 [hp_X] in 1 mL APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 15 [hp_X] in 1 mL BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL LYTTA VESICATORIA (LYTTA VESICATORIA) LYTTA VESICATORIA 15 [hp_X] in 1 mL CROTON TIGLIUM SEED (CROTON TIGLIUM SEED) CROTON TIGLIUM SEED 15 [hp_X] in 1 mL GRAPHITE (GRAPHITE) GRAPHITE 15 [hp_X] in 1 mL GRINDELIA HIRSUTULA FLOWERING TOP (GRINDELIA HIRSUTULA FLOWERING TOP) GRINDELIA HIRSUTULA FLOWERING TOP 15 [hp_X] in 1 mL DAPHNE MEZEREUM BARK (DAPHNE MEZEREUM BARK) DAPHNE MEZEREUM BARK 15 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL RANUNCULUS BULBOSUS (RANUNCULUS BULBOSUS) RANUNCULUS BULBOSUS 15 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 15 [hp_X] in 1 mL SMILAX ORNATA ROOT (SMILAX ORNATA ROOT) SMILAX ORNATA ROOT 15 [hp_X] in 1 mL SULFUR (SULFUR) SULFUR 15 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL RUMEX CRISPUS ROOT (RUMEX CRISPUS ROOT) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL TARAXACUM OFFICINALE (TARAXACUM OFFICINALE) TARAXACUM OFFICINALE 6 [hp_X] in 1 mL URTICA URENS (URTICA URENS) URTICA URENS 6 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55714-4801-1 30 mL in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/02/2019

Labeler — Newton Laboratories, Inc. (788793610)

Registrant — Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Operations
Newton Laboratories, Inc.		788793610	manufacture (55714-4801)

Revised: 12/2020 Newton Laboratories, Inc.