TERPENICOL ANTIFUNGAL- undecylenic acid liquid 
Blaine Labs Inc.

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.

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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

WARNINGS

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

OTHER INFORMATION

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®

TERPENICOLâ„¢

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 LABEL 1

BLAINE TERPENICOL BOX 1


TERPENICOL  ANTIFUNGAL
undecylenic acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63347-600
Route of Administration TOPICAL DEA Schedule     
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 GLYCOLS (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
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)

Revised: 4/2014
Document Id: 8805548f-fbc5-4013-ab04-ceaef3c73db1
Set id: a020334e-aac9-4ea5-a0ea-8e5b021fe2eb
Version: 3
Effective Time: 20140407
 
Blaine Labs Inc.