Medication Guide App

Undesine

Dosage form: ointment
Ingredients: UNDECYLENIC ACID 5g in 100g, ZINC UNDECYLENATE 20g in 100g
Labeler: Indiana Botanic Gardens
NDC Code: 10578-009

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.

Undesine

Active Ingredient

Undecylenic acid    5%

Zinc undecylenate  20%




Purpose

topical antifungal

topical antifungal

Uses:

  • cures athletes foot (dermatophytosis)
  • clears up ringworm (tinea corporis)
  • cures jock itch (tinea cruris)

Warnings: For external use only.

Avoid contact with the eyes.


Do not use:

  • on children under 2 years of age
  • for diaper rash
  • on scalp or nails

Stop using and ask a doctor if

  • irritation occurs
  • if no improvement within 4 weeks

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

Directions:

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • For athlete's foot: pay special attention to spaces between the toes, wear well fitting, ventilated shoes, and change shoes and socks at least once daily
  • use for 4 weeks. (for athlete's foot and ringworm)
  • for jock itch: use daily for 2 weeks


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

UNDESINE 
undecylenic acid, zinc undecylenate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID5 g  in 100 g
ZINC UNDECYLENATE (ZINC UNDECYLENATE) ZINC UNDECYLENATE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL 
PETROLATUM 
METHYLPARABEN 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Indiana Botanic Gardens005421771label, manufacture

Revised: 12/2010
 
Indiana Botanic Gardens

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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