Tea Tree Oil Foot Soak And Body Soak Granule
FDA Label NDC 83691-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sansar, Llc for the product Tea Tree Oil Foot Soak And Body Soak (NDC 83691-003). 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 active ingredient, purpose, uses, warning, direction, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Undecylenate 10%

Purpose

Anti-Fungal

Uses

  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • For effective relief of itching, cracking, burning, redness, soreness, irritation and discomfort

Warning

For External use only
Do not apply to wounds or damaged skin
If pregnant or breast-feeding, ask a health professional before use.
Do not use on children under 2 years of age unless directed by a doctor.

Direction

Fill a foot basin or a bathtub with warm water and add 1 oz of foot soak for every gallon of water, approximately 1.5 Tablespoons. Mix with hand until the salt Dissolves. Soak your feet or body for about 15-20 minutes. Add additional salts for a more stringent or aromatic foot & body bath. If condition persists longer, consult a doctor

Inactive Ingredients

Dead Sea Salt, Epsom Salt, Coconut Oil, Tea Tree Oil, Eucalyptus Oil, Lavender Oil, Peppermint Oil, Rosemary Oil, Spearmint Oil, Chamomile Oil, Sodium Bicarbonate

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