FDA Label for Undesine

View Indications, Usage & Precautions

Undesine Product Label

The following document was submitted to the FDA by the labeler of this product Indiana Botanic Gardens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient

Undecylenic acid    5%

Zinc undecylenate  20%





Otc - 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


Otc - Ask Doctor



Stop using and ask a doctor if

  • irritation occurs
  • if no improvement within 4 weeks

Otc - 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


Otc - Questions




Other information:

To reorder call: 1-800-644-8327

website: www.botanicchoice.com

Use only of seal is unbroken


Other



Manufactured by: Indiana Botanic Gardens, Inc.

NDC# 1057800901


Inactive Ingredient



Inactive ingredients: light mineral oil, white petrolatum, methylparaben


Package Label.Principal Display Panel




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