Undesine
FDA Label NDC 10578-009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Indiana Botanic Gardens for the product Undesine (NDC 10578-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, dosage & administration, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Picture Of Label (Undesine 1oz)

Picture Of Label (Undesine 1oz)

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