Terpenicol Liquid
FDA Label NDC 63347-600

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product Terpenicol (NDC 63347-600). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, indications, warnings, when using this product,, stop use and consult a physician, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 Label1)

Blaine_terpenicol_label1 (Blaine Terpenicol Label1)

Blaine_terpenicol_box1 (Blaine Terpenicol Box1)

Blaine_terpenicol_box1 (Blaine Terpenicol Box1)

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