Label: FUNGICURE ANTI-FUNGAL LIQUID 25%- undecylenic acid liquid
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- NDC Code(s): 0295-9810-05, 0295-9810-10
- Packager: Denison Pharmaceuticals LLC
- 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.
Drug Label Information
Updated February 14, 2019
If you are a consumer or patient please visit this version.
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- Active Ingredient
- Purpose
- Uses
- Warnings
- ASK DOCTOR
- WHEN USING
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
-
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 Liquid 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 ringworm and athlete's foot, use daily for 4 weeks.
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.
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 exposed nail beds, 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
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INGREDIENTS AND APPEARANCE
FUNGICURE ANTI-FUNGAL LIQUID 25%
undecylenic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0295-9810 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 ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0295-9810-05 28 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 02/20/2019 2 NDC:0295-9810-10 38 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 02/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/20/2019 Labeler - Denison Pharmaceuticals LLC (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals LLC 001207208 manufacture(0295-9810)
