FDA.reportPublic FDA data

Rhus Tox 4X / 8X / 12X

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:35:59

Label at a glance#

ProductRhus Tox 4X / 8X / 12X
Active ingredientTOXICODENDRON PUBESCENS LEAF
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS) - equal amounts of: Rhus Toxicodendron 4X, 8X, 12X.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves intense itching & skin irritation from contact with Poison Ivy &/or Poison Oak.**

OTC - PURPOSE SECTION

USES: Temporarily relieves intense itching & skin irritation from contact with Poison Ivy &/or Poison Oak.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate the components in the products are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0216-1

RHUS TOX 4X / 8X / 12X

Homeopathic

1 fl oz (30 mL) / 20% Alcohol

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0216-12022-03-03C16284748780-1d6a99b39-a050-a426-e053-dadaa90af4c2RHUS TOX 4X/8X/12X
43406-0216-12022-01-28C16284748780-1d6a99b39-a050-a426-e053-dadaa90af4c2RHUS TOX 4X/8X/12X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0216-1Rhus Tox 4X / 8X / 12X30 mL in 1 BOTTLE, DROPPERLIQUID304

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-021643406-0216-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rhus Tox 4X / 8X / 12XRHUS TOXICODENDRONNatural Creations, Inc794b33b8-16c7-4137-aaea-1da4bed9b2d62025-12-16WarningsExact identifier
ndc (package): 43406-0216-1
ndc (product): 43406-0216
ndc11 (package): 43406021601
spl id: 3c19ca24-bac3-4f6c-8c8b-b9eeb2fb2a45
spl set id: 794b33b8-16c7-4137-aaea-1da4bed9b2d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.