ZETA CLEAR ANTIFUNGAL- undecylenic acid solution

Zeta Clear Antifungal by

Drug Labeling and Warnings

Zeta Clear Antifungal by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Undecylenic Acid 10.00%

Antifungal

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.

Warnings:

For external use only.

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

DO NOT USE

on diaper rash.

When using this product avoid contact with eyes.

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions:

• 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:

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:

INGREDIENTS AND APPEARANCE

ZETA CLEAR ANTIFUNGAL 
undecylenic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-789
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRONELLA OIL (UNII: QYO8Q067D0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
JOJOBA OIL (UNII: 724GKU717M)
CLOVE OIL (UNII: 578389D6D0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-789-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/17/2017

Labeler - Pure Source, LLC (080354456)