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Fungicure LiquidGel

Dosage form: gel
Ingredients: Undecylenic acid 250mg in 1g
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-633

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.

Drug Facts

Active Ingredient

Undecylenic acid 25% w/w

Purpose

Antifungal

Uses

For the cure of most

  • ringworm (tinea corporis)
  • athlete's foot (tinea pedis)

For relief of

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomforts which may accompany these conditions.

Warnings

For external use only



Ask a doctor before use on children under 2 years of age.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if
  • Irritation occurs
  • There is 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
  • Read all package directions and warnings before use.
  • Use only as directed.
  • Clean the affected area with soap and warm water and dry thoroughly.
  • Apply a thin layer of FUNGICURE over the affected area twice daily (morning and night), or as directed by a doctor.
  • This product is not effective on scalp or nails.
  • For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.  If condition persists longer, consult a doctor.
  • Intended for use by normally healthy adults only.
  • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
  • Supervise children in the use of this product.

Other information
  • FUNGICURE may be applied to cuticles, around nail edges and under nail tips where reachable with its applicator brush.
  • This product is not intended to, nor will it, penetrate hard nail surfaces.
  • While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE until satisfactory results are obtained.
  • You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Aloe vera gel, cyclomethicone, fragrance, isopropyl palmitate, silicon dioxide and vitamin E acetate.

Questions? 1-800-792-2582

FUNGICURE LIQUIDGEL 
undecylenic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-633
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic acid (Undecylenic acid) Undecylenic acid250 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe vera leaf 
SILICON DIOXIDE 
ISOPROPYL PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE 
CYCLOMETHICONE 
Packaging
#Item CodePackage Description
1NDC:52389-633-091 TUBE, WITH APPLICATOR in 1 BOX
19 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/30/2012
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 09/2017
 
Alva-Amco Pharmacal Companies, Inc.

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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