TERPENICOL

Manufacturer
Blaine Labs Inc.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:27

Label at a glance#

ProductTERPENICOL
Active ingredientUNDECYLENIC ACID
Label structure8 sections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

DRUG FACTSACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

UNDECYLENIC ACID 13%

PURPOSE

OTC - PURPOSE SECTION

ANTIFUNGAL

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

INDICATIONS:

INDICATIONS & USAGE SECTION

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 SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

BLAINE TERPENICOL 601BLAINE TERPENICOL 601

res

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-601-012022-02-21C16284748780-1d6a99b39-9c5e-a426-e053-dadaa90af4c2Terpenicol - 601
63347-601-012022-01-28C16284748780-1d6a99b39-9c5e-a426-e053-dadaa90af4c2Terpenicol - 601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-601-01TERPENICOL37.5 mL in 1 BOTTLECREAM37.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-601TERPENICOL (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]3Current NDC, Legacy NDC, 1 package rows20231222_efd99ed1-07d3-4862-ae47-883f7d1c91c6.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63347-60163347-601-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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
TERPENICOLUNDECYLENIC ACIDBlaine Labs Inc.efd99ed1-07d3-4862-ae47-883f7d1c91c62023-12-21WarningsExact identifier
ndc (package): 63347-601-01
ndc (product): 63347-601
ndc11 (package): 63347060101
spl id: f6a16024-2fa1-44ff-a718-af2dc7ae822e
spl set id: efd99ed1-07d3-4862-ae47-883f7d1c91c6

Reported adverse events (FAERS/openFDA)#

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