FUNGICURE ANTI-FUNGAL LIQUID 25%- undecylenic acid liquid 
Denison Pharmaceuticals LLC

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.

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Fungicure Anti-Fungal Liquid 25%

Active Ingredient

Undecylenic acid 25% w/w

Purpose

Antifungal

Uses

For the cure of most

For relief of itching, scaling, cracking, burning, redness, soreness, irritation, and 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


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 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

Inactive ingredients

Isopropyl palmitate

Questions? 1-800-792-2582

label

FUNGICURE ANTI-FUNGAL LIQUID 25% 
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9810
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9810-0528 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product02/20/2019
2NDC:0295-9810-1038 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product02/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/20/2019
Labeler - Denison Pharmaceuticals LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals LLC001207208manufacture(0295-9810)

Revised: 2/2019
Document Id: 81dc6d51-968a-5093-e053-2991aa0a426f
Set id: 81dc6d51-968b-5093-e053-2991aa0a426f
Version: 1
Effective Time: 20190214
 
Denison Pharmaceuticals LLC