UNDESINE- undecylenic acid, zinc undecylenate ointment

Undesine by

Drug Labeling and Warnings

Undesine by is a Otc medication manufactured, distributed, or labeled by Indiana Botanic Gardens. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Undecylenic acid    5%

Zinc undecylenate  20%

PURPOSE

Purpose

topical antifungal

topical antifungal

INDICATIONS & USAGE

Uses:

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

WARNINGS

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
  

ASK DOCTOR

Stop using and ask a doctor if

• irritation occurs
• if no improvement within 4 weeks
  

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.

DOSAGE & ADMINISTRATION

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
  

QUESTIONS

Other information:

To reorder call: 1-800-644-8327

website: www.botanicchoice.com

Use only of seal is unbroken

SPL UNCLASSIFIED SECTION

Manufactured by: Indiana Botanic Gardens, Inc.

NDC# 1057800901

INACTIVE INGREDIENT

Inactive ingredients: light mineral oil, white petrolatum, methylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNDESINE 
undecylenic acid, zinc undecylenate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10578-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	5 g  in 100 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (ZINC UNDECYLENATE - UNII:388VZ25DUR)	ZINC UNDECYLENATE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10578-009-01	29 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/1995

Labeler - Indiana Botanic Gardens (005421771)

Registrant - Indiana Botanic Gardens (005421771)

Establishment
Name	Address	ID/FEI	Business Operations
Indiana Botanic Gardens		005421771	label, manufacture