FDA.reportPublic FDA data

Rhus Tox 4X, 8X, 12X

Manufacturer
OHM PHARMA INC.
Effective date
2017-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:36

Label at a glance#

ProductRhus Tox 4X, 8X, 12X
Active ingredientTOXICODENDRON PUBESCENS LEAF
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*):

Rhus Toxicodendron 4X, 8X, 12X

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

INDICATIONS & USAGE SECTION

USES: Temporarily relieves blistering rash.**

** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

OTC - PURPOSE SECTION

Temporarily relieves blistering rash.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 3 dropperfulls in mouth and hold for 1 minute before swallowing. Repeat once a week for 3 weeks, or as directed by a health care professional.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Purified Water, Ethyl Alcohol USP.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?:

Little Drug / Sweetwater, TN 37874 / 423-337-7933

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LITTLE DRUG

FAMILY WELLNESS CENTER

NDC: 66096-715-02

RHUS TOX

4X, 8X, 12X

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

1oz bottle label1oz bottle label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66096-715-022020-01-31C16284748780-19d75b9cf-d289-f424-e053-dadaa90a57ceRHUS TOX 4X, 8X, 12X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-715-02Rhus Tox 4X, 8X, 12X30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-715RHUS TOX 4X, 8X, 12X (RHUS TOXICODENDRON.) LIQUID [OHM PHARMA INC.]1Legacy NDC, 1 package rows20170308_9c501973-65e1-4b8b-bbff-95d9d7e8cb60.zip

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
66096-71566096-715-02

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
5904ff35-00e9-434f-9b4c-c23bd8321bd19c501973-65e1-4b8b-bbff-95d9d7e8cb602017-03-08WarningsExact identifier
spl id: 5904ff35-00e9-434f-9b4c-c23bd8321bd1
spl set id: 9c501973-65e1-4b8b-bbff-95d9d7e8cb60

Reported adverse events (FAERS/openFDA)#

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