Your browser does not support JavaScript! CVS PHARMACY ANTI-FUNGAL PEN MAXIMUM STRENGTH (UNDECYLENIC ACID) LIQUID [CVS PHARMACY]
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CVS PHARMACY ANTI-FUNGAL PEN MAXIMUM STRENGTH (undecylenic acid) liquid
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active Ingredient

Undecylenic Acid 25%

Purpose

Anti-fungal

Uses

For the cure of most:

  • ringworm (tinea corporis)
  • athlete’s foot (tinea pedis)

For the relief of:

  • itching
  • scaling
  • crackling
  • burning
  • redness
  • soreness
  • irritation and discomfort which may accompany these conditions

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

  • irritation occurs
  • there is no improvement within 4 weeks

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

Directions

  • read all warnings and directions
  • use only as directed
  • clean the affected area with soap and water and dry thoroughly
  • remove cap from pen
  • twist the base of the pen, with brush pointing downward, until product dispenses
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
  • for athlete’s foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete’s foot and ringworm, use daily for 4 weeks. 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
  • this product is not effective on the scalp or nails

Other Information

  • Store at 15°-30C° (59°-86°F)
  • Keep cap on pen when not in use

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
 
CVS Pharmacy

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