UNDESINE - undecylenic acid, zinc undecylenate ointment 
Indiana Botanic Gardens

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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Undesine

Active Ingredient

Undecylenic acid    5%

Zinc undecylenate  20%




Purpose

topical antifungal

topical antifungal

Uses:

Warnings: For external use only.

Avoid contact with the eyes.


Do not use:


Stop using and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:



Other information:

To reorder call: 1-800-644-8327

website: www.botanicchoice.com

Use only of seal is unbroken

Manufactured by: Indiana Botanic Gardens, Inc.

NDC# 1057800901

Inactive ingredients: light mineral oil, white petrolatum, methylparaben

picture of label

UNDESINE 
undecylenic acid, zinc undecylenate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID5 g  in 100 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (ZINC UNDECYLENATE - UNII:388VZ25DUR) ZINC UNDECYLENATE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10578-009-0129 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/1995
Labeler - Indiana Botanic Gardens (005421771)
Registrant - Indiana Botanic Gardens (005421771)
Establishment
NameAddressID/FEIBusiness Operations
Indiana Botanic Gardens005421771label, manufacture

Revised: 12/2010
Document Id: b47f0974-039f-4e18-b1a5-72b4fe282c58
Set id: 730ecb18-b67f-403f-95db-1fb79f06d61d
Version: 1
Effective Time: 20101201
 
Indiana Botanic Gardens