FUNGICURE MANICURE PEDICURE ANTI FUNGAL- 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 Manicure Pedicure Anti Fungal Liquid

Active ingredient

Clotrimazole 1% w/v.

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:

For relief of:

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

Inactive ingredient

Isopropyl alcohol

Directions

Other information

Questions? 1-800-792-2582

labeldrug facts

FUNGICURE MANICURE PEDICURE ANTI FUNGAL 
clotrimazole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-6307
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-6307-0530 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/12/2018
2NDC:0295-6307-4460 mL in 1 BOTTLE, 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(0295-6307)

Revised: 1/2019
Document Id: 7f9a0062-0ef2-1deb-e053-2a91aa0a9188
Set id: 7cdb02c6-7464-3c7b-e053-2991aa0a3b06
Version: 3
Effective Time: 20190116
 
Denison Pharmaceuticals, LLC