FUNGICURE LIQUID GEL- clotrimazole 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 Liquid Gel

Active ingredient

Clotrimazole 1% w/w.

Purpose

Antifungal

Keep out of reach of children. If swallowed, get medical help or contact a poison center right away.

Uses

For the cure of most:

  • ringworm (tinea corpis)
  • 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

Inactive ingredient

Hydroxypropylcellulose and Isopropyl alcohol

Directions

  • Read and all package directions and warnings before using.
  • Use only as directed.
  • Clean the affected area with soap with 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 the scalp or nails.
  • Avoid applying to severly cracked or irritated areas.
  • For ringworm and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor.
  • 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.
  • Intented 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 Questions? below

Questions? 1-800-792-2582

label

FUNGICURE LIQUID GEL 
clotrimazole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1363
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1363-3110.5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product12/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/12/2018
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-1363)

Revised: 1/2019
 
Denison Pharmaceuticals, LLC