Label: TERPENICOL ANTIFUNGAL- undecylenic acid liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 21, 2023

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  • ACTIVE INGREDIENT

    DRUG FACTS

    ACTIVE INGREDIENT

    UNDECYLENIC (10-UNDECENOIC) ACID

  • 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 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

    • 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,

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

  • STOP USE AND CONSULT A PHYSICIAN

    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

    • 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

    • STORE AT ROOM TEMPERATURE
  • INACTIVE INGREDIENTS OTHER INGREDIENTS

    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

    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_Label1

    Blaine_Terpenicol_box1

    res

  • INGREDIENTS AND APPEARANCE
    TERPENICOL  ANTIFUNGAL
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    UREA (UNII: 8W8T17847W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    COCONUT ACID (UNII: 40U37V505D)  
    LAURETH-4 (UNII: 6HQ855798J)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLIC ALCOHOL (UNII: NV1779205D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63347-600-0137.5 mL in 1 JAR; Type 0: Not a Combination Product04/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/01/2014
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture(63347-600)