Label: TERPENICOL ANTIFUNGAL- undecylenic acid liquid 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/14

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  • ACTIVE INGREDIENT

    DRUG FACTS

    ACTIVE INGREDIENT

    UNDECYLENIC (10-UNDECENOIC) ACID

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  • PURPOSE

    ANTIFUNGAL

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  • 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.

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  • 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
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  • 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
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  • WHEN USING THIS PRODUCT,

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

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  • 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)..

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  • 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
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  • OTHER INFORMATION

    • STORE AT ROOM TEMPERATURE
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  • 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

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  • TERPENICOL PRODUCT LABEL LABEL BOX

    DISPENSED EXCLUSIVELY BY PHYSICIANS

    NDC 63347-600-01

    BLAINE LABS®

    TERPENICOLâ„¢

    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 LABEL 1

    BLAINE TERPENICOL BOX 1


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  • INGREDIENTS AND APPEARANCE
    TERPENICOL  ANTIFUNGAL
    undecylenic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63347-600
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID 25 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    OREGANO LEAF OIL  
    GRAPE SEED OIL  
    POLYSORBATE 20  
    GLYCERYL MONOSTEARATE  
    PROPYLENE GLYCOL  
    UREA  
    GLYCERIN  
    CETYL ALCOHOL  
    PEG-7 GLYCERYL COCOATE  
    SORBITAN MONOLAURATE  
    POLYETHYLENE GLYCOLS  
    COCONUT ACID  
    LAURETH-4  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)  
    PHENOXYETHANOL  
    CAPRYLIC ALCOHOL  
    ETHYLHEXYLGLYCERIN  
    HEXYLENE GLYCOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63347-600-01 37.5 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 04/01/2014
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    Name Address ID/FEI Business Operations
    Blaine Labs Inc. 017314571 manufacture(63347-600)
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