FDA.reportPublic FDA data

TERPENICOL

Manufacturer
Blaine Labs Inc.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:05:24

Label at a glance#

ProductTERPENICOL ANTIFUNGAL
Active ingredientUNDECYLENIC ACID
Label structure11 sections

Dosage and administration

WASH THE AFFECTED AREA WITH SOAP AND WATER, DRY THOROUGHLY, THEN APPLY A HEAVY LAYER OVER THE AFFECTED AREA. USE TWICE DAILY (MORNING AND NIGHT) OR AS DIRECTED BY A PHYSICIAN SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT FOR ATHLETE'S: PAY SPECIAL ATTENTION TO SPACES BETWEEN TOES ; WEAR WELL-FITTING, VENTILATED SHOES AND CHANGE SOCKS AT LEAST ONCE, DAILY FOR ATHLETE'S FOOT AND RINGWORM, USE DAILY FOR FOUR (4) WEEK...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

ACTIVE INGREDIENT

UNDECYLENIC (10-UNDECENOIC) ACID

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 MOST ATHLETE'S FOOT (TINEA PEDIS)
  • CURES MOST JOCK ITCH (TINEA CRURIS) AND RELIEVES ITCHING, CRACKING, BURNING AND SCALING, WHICH ACCOMPANY THESE CONDITIONS
  • PREVENTS MOST ATHLETE'S FOOT (TINEA PEDIS) WITH DAILY USE

WARNINGS

WARNINGS SECTION

  • DO NOT USE:
  • ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A PHYSICIAN
  • IN OR NEAR THE MOUTH OR THE EYES
  • FOR VAGINAL YEAST INFECTIONS

WHEN USING THIS PRODUCT,

OTC - WHEN USING SECTION

AVOID CONTACT WITH THE EYES. IF EYE CONTACT OCCURS, WASH THOROUGHLY WITH WATER.

STOP USE AND CONSULT A PHYSICIAN

OTC - STOP USE SECTION

IF IRRITATION OCCURS OR IF THERE IS NO IMPROVEMENT WITHIN FOUR (4) WEEKS (FOR ATHLETE'S FOOT OR RINGWORM) OR WITHIN TWO (2) WEEKS (FOR JOCK ITCH)..

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • WASH THE AFFECTED AREA WITH SOAP AND WATER, DRY THOROUGHLY, THEN APPLY A HEAVY LAYER OVER THE AFFECTED AREA. USE TWICE DAILY (MORNING AND NIGHT) OR AS DIRECTED BY A PHYSICIAN
  • SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT
  • FOR ATHLETE'S: PAY SPECIAL ATTENTION TO SPACES BETWEEN TOES ; WEAR WELL-FITTING, VENTILATED SHOES AND CHANGE SOCKS AT LEAST ONCE, DAILY
  • FOR ATHLETE'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

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

CYMOPHENOL (CARVACROL), UREA, AQUA (WATER), ORGANIC VULGARE (WILD OREGANO) ESSENTIAL OIL, VITIT VINFER (GRAPE) SEED OIL, POLYSORBATE 20, GLYCERYL STEARATE, PROPYLENE GLYCOL, UREA, GLYCERIN, CETYL ALCOHOL, POLYETHYLENE GLYCOL COCOATE, SORBITAN LAURATE, POLYETHYLENE GLYCOL DICOCOATE, POLYETHYLENE GLYCOL, FATTY ACIDS, COCO, LAURETH-4, HYDROXYETHYLCELLULOSE, PHENOXYETHANOL CAPRYLY ALCOHOL, ETHYLHEXYL GLYCERIN, HEXYLENE GLYCOL

TERPENICOL PRODUCT LABEL LABEL BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISPENSED EXCLUSIVELY BY PHYSICIANS

NDC 63347-600-01

BLAINE LABS®

TERPENICOL™

ANTIFUNGAL SOLUTION

10-UNDECENOIC ACID

IN A SOLUTION CONTAINING CYMOPHENOL AND UREA

37.5 mL (1.25 FL OZ)

SEE OPPOSITE PANEL FOR MORE INFORMATION.

* MADE IN THE U.S.A.

PLEASE RECYCLE! THIS PACKAGE IS MADE FROM RECYCLABLE MATERIALS.

TEPENICOL ANTIFUNGAL
SOLUTION IS BACKED BY BLAINE LABS®
100 PERCENT, PATIENT-DIRECT, MONEY-BACK GUARANTEE. CALL THE NUMBER BELOW FOR MORE INFORMATION.

QUESTIONS OR COMMENTS?
CALL (800) 307-8818, M-F, 8:00 AM - 5:00 pm (PST)

MANUFACTURED BY:
BLAINE LABS, INC.
11037 LOCKPORT PLACE
SANTE FE SPRINGS, CA 90670

31000-P-BX01
REV20140217

Blaine_Terpenicol_Label1Blaine_Terpenicol_Label1

Blaine_Terpenicol_box1Blaine_Terpenicol_box1

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN6
998329undecylenic acid 250 MG/ML Topical SolutionSCD6
998329undecylenic acid 25 % Topical SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-600-01TERPENICOLANTIFUNGAL37.5 mL in 1 JARLIQUID37.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-600TERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]6Current NDC, Legacy NDC, 1 package rows20231222_a020334e-aac9-4ea5-a0ea-8e5b021fe2eb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24N3
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24N3
CAPRYLIC ALCOHOLINACTIVE INGREDIENTNV1779205D3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN3
COCONUT ACIDINACTIVE INGREDIENT40U37V505D3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE43
GRAPE SEED OILINACTIVE INGREDIENT930MLC8XGG3
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J3
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY53
LAURETH-4INACTIVE INGREDIENT6HQ855798J3
OREGANO LEAF OILINACTIVE INGREDIENT7D0CGR40U13
PEG-7 GLYCERYL COCOATEINACTIVE INGREDIENTVNX72515433
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71J3
UREAINACTIVE INGREDIENT8W8T17847W3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63347-60063347-600-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
WATER059QF0KO0RIACT
OREGANO LEAF OIL7D0CGR40U1IACT
GRAPE SEED OIL930MLC8XGGIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
UREA8W8T17847WIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
SORBITAN MONOLAURATE6W9PS8B71JIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
COCONUT ACID40U37V505DIACT
LAURETH-46HQ855798JIACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLIC ALCOHOLNV1779205DIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 146 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route
46 equally ranked IID candidates
COCONUT ACIDCOCONUT ACID40U37V505DSOLUTION / TOPICAL0.7 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route
46 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii+route
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+dosage form
46 equally ranked IID candidates
LAURETH-4LAURETH-46HQ855798JCREAM / TOPICAL1.1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SUSPENSION / ORAL1200 mgExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii+route
46 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii+route
8 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii+route
46 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET, EXTENDED RELEASE / ORAL150 mgExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT ACIDCOCONUT ACID40U37V505DSHAMPOO / TOPICAL3 %w/wExact identifier — unii+route
6 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii+route
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii+route
16 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii+route
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii+route
16 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii+route
8 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii+route
16 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
46 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5CAPSULE / ORAL20 mgExact identifier — unii candidate
18 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
12 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
UREAUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii+route
2 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii+route
18 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
12 equally ranked IID candidates
UREAUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii+route
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route
46 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SYRUP / ORAL100 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT ACIDCOCONUT ACID40U37V505DSOLUTION / TOPICAL0.7 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii+route
46 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route
46 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii+route
18 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route
18 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / TOPICAL3.7 %w/wExact identifier — unii+route
18 equally ranked IID candidates
LAURETH-4LAURETH-46HQ855798JLOTION / TOPICAL1.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route
46 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii+route
16 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / TOPICAL3.7 %w/wExact identifier — unii+route
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SUSPENSION / ORAL1200 mgExact identifier — unii candidate
18 equally ranked IID candidates
LAURETH-4LAURETH-46HQ855798JGEL / TOPICAL60 mgExact identifier — unii+route
8 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii+route
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii+route
46 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii+route
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii+route
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii+route
46 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5FILM, SOLUBLE / BUCCAL161 mgExact identifier — unii candidate
18 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii+route
18 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii+route
12 equally ranked IID candidates

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
TERPENICOL ANTIFUNGALUNDECYLENIC ACIDBlaine Labs Inc.a020334e-aac9-4ea5-a0ea-8e5b021fe2eb2023-12-21WarningsExact identifier
ndc (package): 63347-600-01
ndc (product): 63347-600
ndc11 (package): 63347060001
spl id: 92f83cae-7224-46f8-a9ac-550118c21f29
spl set id: a020334e-aac9-4ea5-a0ea-8e5b021fe2eb

Reported adverse events (FAERS/openFDA)#

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