Label: FUNGICURE LIQUIDGEL- undecylenic acid gel
- NDC Code(s): 52389-633-09
- Packager: Alva-Amco Pharmacal Companies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated September 5, 2017
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- Active Ingredient
Undecylenic acid 25% w/wClose
For the cure of most
- ringworm (tinea corporis)
- athlete's foot (tinea pedis)
For relief of
- discomforts which may accompany these conditions.
For external use only
- ASK DOCTOR
Ask a doctor before use on children under 2 years of age.Close
- WHEN USING
When using this product avoid contact with the eyes.Close
- 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.Close
- 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.Close
- INGREDIENTS AND APPEARANCE
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)