ANTIFUNGAL PEN- undecylenic acid 25% liquid

Antifungal Pen by

Drug Labeling and Warnings

Antifungal Pen by is a Otc medication manufactured, distributed, or labeled by XF Agencija Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses

For the treatment of athlete's foot, jock itch, and ringworm.

Warnings

For external use only.

DO NOT USE

Do not use on children under 2 years of age unless directed by a doctor.

WHEN USING

When using this product avoid contact with eyes.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

■ Read all warnings and directions

■ Use only as directed
■ Clean the affected area with soap and water and dry thoroughly

■ Remove cap from pen

■ Twist the base of the pen, with brush pointing downward, until product dispenses

■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor

■ For athlete's foot, pay special attention to spaces between the toes; wear well-fitting,ventilated shoe, and change shoes and socks at least once daily.

Other information

■ Store at 15°-30°C (59° - 86°F)
■ Keep cap on pen when not in use

Inactive Ingredients

Aloe Vera Extract, Sweet Almond Oil, Jojoba Oil, Tea Tree Oil, Manuka Oil, Clove Bud Oil, Lavender Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Tocopheryl Acetate (Vitamin E).

NDC:

85210-001-01 (01 Pen 3 mL)

NDC:

85210-001-02 (03 Pens 9 mL)

NDC:

85210-001-03 (06 Pens 18 mL)

INGREDIENTS AND APPEARANCE

ANTIFUNGAL PEN 
undecylenic acid 25% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85210-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
TEA TREE OIL (UNII: VIF565UC2G)
MANUKA OIL (UNII: M6QU9ZUH2X)
CLOVE OIL (UNII: 578389D6D0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85210-001-01	1 in 1 CARTON	01/28/2025
1		3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 85210-001-02	3 in 1 CARTON	01/28/2025
2		3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 85210-001-03	6 in 1 CARTON	01/28/2025
3		3 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	01/28/2025

Labeler - XF Agencija Limited (687239979)