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TERPENICOL ANTIFUNGAL

Medically reviewed on April 9, 2018

Dosage form: liquid
Ingredients: UNDECYLENIC ACID 25g in 100mL
Labeler: Blaine Labs Inc.
NDC Code: 63347-600

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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



TERPENICOL  ANTIFUNGAL
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-600
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:63347-600-0137.5 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/01/2014
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIOperations
Blaine Labs Inc.017314571manufacture(63347-600)

 
Blaine Labs Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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