SPL v6
SPL
SPL Set ID a020334e-aac9-4ea5-a0ea-8e5b021fe2eb
Route
TOPICAL
Published
Effective Date 2020-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g)
Inactive Ingredients
Water Oregano Leaf Oil Grape Seed Oil Polysorbate 20 Glyceryl Monostearate Propylene Glycol Urea Glycerin Cetyl Alcohol Peg-7 Glyceryl Cocoate Sorbitan Monolaurate Polyethylene Glycol Coconut Acid Laureth-4 Hydroxyethyl Cellulose (140 Mpa.s At 5%) Phenoxyethanol Caprylic Alcohol Ethylhexylglycerin Hexylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-04-01

Description

DRUG FACTS ACTIVE INGREDIENT UNDECYLENIC (10-UNDECENOIC) ACID

Purpose

ANTIFUNGAL


Medication Information

Purpose

ANTIFUNGAL

Description

DRUG FACTS ACTIVE INGREDIENT UNDECYLENIC (10-UNDECENOIC) ACID

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

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

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

Active Ingredient

DRUG FACTS



ACTIVE INGREDIENT



UNDECYLENIC (10-UNDECENOIC) ACID

Other Information
  • STORE AT ROOM TEMPERATURE

When Using This Product,

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

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.

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)..

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

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


Structured Label Content

Purpose (PURPOSE)

ANTIFUNGAL

Warnings (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

Directions (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

Indications (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

Active Ingredient (ACTIVE INGREDIENT)

DRUG FACTS



ACTIVE INGREDIENT



UNDECYLENIC (10-UNDECENOIC) ACID

Other Information (OTHER INFORMATION)
  • STORE AT ROOM TEMPERATURE

When Using This Product, (WHEN USING THIS PRODUCT,)

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

Keep Out of Reach of Children (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.

Stop Use and Consult A Physician (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)..

Terpenicol Product Label Label Box (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

Inactive Ingredients Other Ingredients (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


Advanced Ingredient Data


Raw Label Data

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