FDA.reportPublic FDA data

Tea Tree Oil Foot Soak and Body Soak

Manufacturer
SANSAR, LLC
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:09

Label at a glance#

ProductTea Tree Oil Foot Soak and Body Soak
Active ingredientZinc Undecylenate
Label structure11 sections

Indications and 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Undecylenate 10%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

OTC - WHEN USING SECTION

When using this product Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor If irritation occurs or if there is no improvement within 4 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

Direction

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

Email: sales@gofootcure.com   or  www.gofootcure.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tea Tree OilTea Tree Oil

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83691-003-01Tea Tree Oil Foot Soak and Body Soak453 g in 1 POUCHGRANULE4531
83691-003-02Tea Tree Oil Foot Soak and Body Soak2 in 1 BAGGRANULE21
83691-003-02Tea Tree Oil Foot Soak and Body Soak453 g in 1 POUCHGRANULE4531
83691-003-03Tea Tree Oil Foot Soak and Body Soak453 g in 1 POUCHGRANULE4531
83691-003-03Tea Tree Oil Foot Soak and Body Soak4 in 1 BAGGRANULE41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83691-003TEA TREE OIL FOOT SOAK AND BODY SOAK (ZINC UNDECYLENATE) GRANULE [SANSAR, LLC]1Current NDC, 5 package rows20250331_c43816ac-2228-43ce-ba45-80cf3a7788f2.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83691-00383691-003-01, 83691-003-02, 83691-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc Undecylenate388VZ25DURACTIB
SEA SALT87GE52P74GIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
COCONUT OILQ9L0O73W7LIACT
TEA TREE OILVIF565UC2GIACT
EUCALYPTUS OIL2R04ONI662IACT
Lavender OilZBP1YXW0H8IACT
PEPPERMINT OILAV092KU4JHIACT
ROSEMARY OIL8LGU7VM393IACT
SPEARMINT OILC3M81465G5IACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
Sodium Bicarbonate8MDF5V39QOIACT

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
Tea Tree Oil Foot Soak and Body SoakZINC UNDECYLENATESANSAR, LLCc43816ac-2228-43ce-ba45-80cf3a7788f22025-03-28WarningsExact identifier
ndc (package): 83691-003-01
ndc (package): 83691-003-02
ndc (package): 83691-003-03
ndc (product): 83691-003
ndc11 (package): 83691000303
ndc11 (package): 83691000302
ndc11 (package): 83691000301
spl id: 6a4e3e56-e905-4ce8-9372-0c873db9b901
spl set id: c43816ac-2228-43ce-ba45-80cf3a7788f2

Reported adverse events (FAERS/openFDA)#

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