Drug Factsactive Ingredient
UNDECYLENIC ACID 13%
Terpenicol Cream
FDA Label NDC 63347-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product Terpenicol (NDC 63347-601). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug factsactive ingredient, purpose, keep out of reach of children, indications:, warnings:, directions:, inactive ingredients:, terpenicol antifungal cream product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTIFUNGAL
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.
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:
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.
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:
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
Terpenicol Antifungal Cream Product Label
DISPENSED EXCLUSIVELY BY PHYSICIANS
NDC-601-01
BLAINE LABS®
TERPENICOL®
ANTIFUNGAL CREAM
UNDECYLENIC ACID
37.5 mL (1.25 FL OZ)
BLAINE LABS, INC., 11037 LOCKPORT PLACE,
SANTA FE SPRINGS, CA 90670
(800) 307-8818
31100-P-LBL01 REV20170517
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