FDA Label for Terpenicol Antifungal
View Indications, Usage & Precautions
Terpenicol Antifungal Product Label
The following document was submitted to the FDA by the labeler of this product Blaine Labs Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
res
* Please review the disclaimer below.