Rhus Tox 6x/12x Liquid
FDA Label NDC 82406-0001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medcara Pharmaceuticals, Llc for the product Rhus Tox 6x/12x (NDC 82406-0001). 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, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS equal amounts of: Rhus Toxicodendron 6X, 12X HPUS*

Indications & Usage

USES: Temporarily relieves irritation from red, swollen, itchy skin.**

Otc - Purpose

USES: Temporarily relieves irritation from red, swollen, itchy skin.**

Dosage & Administration

DIRECTIONS: Adults and children above 12 years: 3 droppers full 1 time per week for 3 weeks, then 1 time per month thereafter, hold solution in mouth for 30 seconds then swallow. Can be taken at any time of year but ideal to begin administering during Poison Ivy dormant phase (winter) often starting in February in the Midwest.

Otc - Keep Out Of Reach Of Children

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

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

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Otc - Questions

QUESTIONS & COMMENTS?

MedCara / Conrad, IA 50621 / 855-409-5496

www.outdoorjoes.com

References

*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: 82406-0001-1

RHUS TOX 6X / 12X

Homeopathic

1 fl oz (30 mL) / 20% Alcohol

* Please review the disclaimer below.