CVS PHARMACY ANTI-FUNGAL PEN MAXIMUM STRENGTH- undecylenic acid liquid 
CVS Pharmacy

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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CVS Pharmacy Anti-Fungal Pen Maximum Strength - Drug Facts

Active Ingredient

Undecylenic Acid 25%

Purpose

Anti-fungal

Uses

For the cure of most:

For the relief of:

Warnings

For external use only

Ask a doctor before use on children under 2 years of age

Do not use on diaper rash

When using this product avoid contact with the eyes

Stop use and ask doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Isopropyl Palmitate, Propylparaben

Questions or Comments?

1-800-526-FOOT (3668) Mon-Fri 9AM - 5 PM EST

Image of Label and Carton

CVSAntifungalPenLabel.jpgLabel CVSAntiFungalPenCartonFinal.jpgCarton

CVS PHARMACY  ANTI-FUNGAL PEN MAXIMUM STRENGTH
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-965
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE 
PROPYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-965-021 in 1 BOX
1NDC:59779-965-011.7 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/27/2012
Labeler - CVS Pharmacy (062312574)
Registrant - Dhaliwal Labs (016754201)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Labs016754201manufacture(59779-965)

Revised: 11/2013
Document Id: 80dc6314-829b-4829-93d7-fe8de4b3f817
Set id: 84493c06-248d-48fc-a59b-8a3cc078879d
Version: 2
Effective Time: 20131112
 
CVS Pharmacy