FUNGICURE LIQUIDGEL- undecylenic acid gel

Fungicure LiquidGel by

Drug Labeling and Warnings

Fungicure LiquidGel by is a Otc medication manufactured, distributed, or labeled by Alva-Amco Pharmacal Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 DOCTOR

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

WHEN USING

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

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

Questions? 1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGICURE LIQUIDGEL 
undecylenic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-633
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	250 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOMETHICONE (UNII: NMQ347994Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-633-09	1 in 1 BOX	06/05/2016
1		9 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/30/2012

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)