Terpenicol

Undecylenic Acid · Liquid · Topical

Over the counter 2 recalls

Active ingredient

13%

Purpose

PURPOSE ANTIFUNGAL

Uses

INDICATIONS: CURES ATHLETE'S FOOT (TINEA PEDIS), JOCK ITCH (TINA CRURIS) AND RINGWORM (TINA CORPORIS). RELIEVES ITCHING, BURNING, CRACKING, SCALING, ITCHY, SCALY BETWEEN TOES AND ITCHING, BURNING FEET.

Warnings

WARNINGS: DO NOT USE ON CHILDREN UNDER TWO YEARS OF AGE UNLESS DIRECTED BY A PHYSICIAN. FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. IF IRRITATION OCCURS OR IF THERE IS NOT IMPROVEMENT WITHIN FOUR (4) WEEKS (FOR ATHLETE'S FOOT OR RINGWORM) OR WITHIN TWO (2) WEEKS (FOR JOCK ITCH), DISCONTINUE USE AND CONSULT A PHYSICIAN.

Keep out of reach of children

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

DIRECTIONS: WASH THE AFFECTED AREA WITH SOAP AND WATER AND DRY THOROUGHLY. APPLY A THIN LAYER OF THE PRODUCT OVER AFFECTED AREA TWICE DAILY (MORNING AND NIGHT), OR AS DIRECTED BY A PHYSICIAN. FOR ATHLETE'S FOOT, PAY SPECIAL ATTENTION TO SPACES BETWEEN THE TOES; WEAR WELL-FITTING, VENTILATED SHOES AND CHANGE SHOES AND SOCKS AT LEAST ONCE DAILY. FOR ALHTLETE'S FOOT AND RINGWORM, USE DAILY FOR FOUR (4) WEEKS. FOR JOCK ITCH, USE DAILY FOR TWO (2) WEEKS. IF CONDITION PERSISTS LONGER, CONSULT A PHYSICIAN. WASH HANDS AFTER EACH USE.

Inactive ingredients

INACTIVE INGREDIENTS: WATER, UREA, HYDROXYETHYLCELLULOSE, DISODIUM EDTA, C12-15 ALKYL BENZOATE, POLYSORBATE 80, SORBITAN LAURATE, CETYL ALCOHOL, GLYCOL STEARATE, PEG-100 STEARATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, ALOE BARDADENSIS LEAF JUICE, CLOTRIMAZOLE, TRIETHANOLAMINE, METHYLPARABEN, PROPYLPARABEN

Label text from the FDA structured product label by Blaine Labs Inc. (revised Dec 21, 2023). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Terpenicol NDC products (2)

NDCStrength & formLabelerType
63347-600Undecylenic Acid 25 g/100mL
Liquid
Blaine Labs Inc.OTC MONOGRAPH DRUG
63347-601Undecylenic Acid 4.55 g/37.5mL
Cream
Blaine Labs Inc.OTC MONOGRAPH DRUG

Terpenicol recalls

Frequently asked questions

What is Terpenicol used for?

INDICATIONS: CURES ATHLETE'S FOOT (TINEA PEDIS), JOCK ITCH (TINA CRURIS) AND RINGWORM (TINA CORPORIS). RELIEVES ITCHING, BURNING, CRACKING, SCALING, ITCHY, SCALY BETWEEN TOES AND ITCHING, BURNING FEET.

Who makes Terpenicol?

Terpenicol is listed by 1 labeler in the FDA NDC directory, including Blaine Labs Inc..

Has Terpenicol been recalled?

The FDA enforcement database lists 2 recalls for Terpenicol, most recently D-0695-2026 (class ii): CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry