TERPENICOL ANTIFUNGAL- undecylenic acid liquid

TERPENICOL by

Drug Labeling and Warnings

TERPENICOL by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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INGREDIENTS AND APPEARANCE

TERPENICOL  ANTIFUNGAL
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
GRAPE SEED OIL (UNII: 930MLC8XGG)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
UREA (UNII: 8W8T17847W)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
COCONUT ACID (UNII: 40U37V505D)
LAURETH-4 (UNII: 6HQ855798J)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLIC ALCOHOL (UNII: NV1779205D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-600-01	37.5 mL in 1 JAR; Type 0: Not a Combination Product	04/01/2014

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)