CVS MAXIMUM STRENGTH ANTI-FUNGAL PEN 25%- undecylenic acid liquid 
Denison Pharmaceuticals, LLC

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Maximum Strength Anti-Fungal Pen 25%

Active ingredient

Undecylenic acid 25%

Purpose

Anti-fungal

Uses

For the cure of most

  • ringworm (tinea capitis)
  • athlete's foot (tinea pedis)

For the 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

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out 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, 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; 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.
  • supervise children in the use of this product
  • this product is not effective on the scalp or nails

Other information

  • Store at 15 o - 30 oC (59 o - 86 oF)
  • Keep cap on pen when not in use

Inactive ingredient

Isopropyl Palmitate

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CVS MAXIMUM STRENGTH ANTI-FUNGAL PEN 25% 
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9008-163 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00501/09/201910/12/2023
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-9008)

Revised: 10/2023
 
Denison Pharmaceuticals, LLC