FDA.reportPublic FDA data

Zeta Clear Antifungal

Manufacturer
Pure Source, LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:45:59

Label at a glance#

ProductZeta Clear Antifungal
Active ingredientUNDECYLENIC ACID
Label structure6 sections

Indications and uses

For cure of most: - ring worm (tinea corporis)   - athlete's foot (tinea pedis). For the relief of: - itching; - scaling; -cracking; - burning; - redness; - soreness;  - irritation and discomforts which may accompany these conditions.

Dosage and administration

Clean and dry affected area with soap and water and dry thoroughly. Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician. For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. For athlete's foot and ring worm.  If condition persists for longer, consult a physician. Intended for use by normally healthy...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 10.00%

OTC - PURPOSE SECTION

Antifungal

Uses:

INDICATIONS & USAGE SECTION

For cure of most:

- ring worm (tinea corporis)   - athlete's foot (tinea pedis).

For the relief of:

- itching; - scaling; -cracking; - burning; - redness; - soreness;  - irritation and discomforts which may accompany these conditions.

Warnings:

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use on children under 2-years of age.

DO NOT USE

OTC - DO NOT USE SECTION

on diaper rash.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within four weeks.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Clean and dry affected area with soap and water and dry thoroughly.
  • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician.
  • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks.
  • For athlete's foot and ring worm.  If condition persists for longer, consult a physician.
  • Intended for use by normally healthy adults only.  Persons under the age of 18, or those with highly sensitive or allergic skins hould use only as directed by physician.
  • This product is not meant to be applied directly to the scalp or nails.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Cymbopogon Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65121-78965121-789-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRONELLA OILQYO8Q067D0IACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
JOJOBA OIL724GKU717MIACT
CLOVE OIL578389D6D0IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

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
292778ae-2fb5-bcf5-e063-6294a90a9c11490b65ba-c9c2-17db-e054-00144ff8d46c2024-12-13WarningsExact identifier
spl id: 292778ae-2fb5-bcf5-e063-6294a90a9c11
spl set id: 490b65ba-c9c2-17db-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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