cvs pharmacy anti-fungal pen maximum strength - drug facts

cvs pharmacy anti-fungal pen maximum strength - drug facts
SPL v9
SPL
SPL Set ID 84493c06-248d-48fc-a59b-8a3cc078879d
Route
topical
Published
Effective Date 2013-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
undecylenic acid (250 mg)
Inactive Ingredients
isopropyl palmitate propylparaben

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-12-27

Purpose

Anti-fungal

Description

Undecylenic Acid 25%


Medication Information

Warnings

For external use only

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
Purpose

Anti-fungal

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

Description

Undecylenic Acid 25%

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
Section 50567-7

When using this product avoid contact with the eyes

Section 50569-3

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

Section 50570-1

Do not use on diaper rash

Active Ingredient

Undecylenic Acid 25%

Questions Or Comments?

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

Image of Label and Carton

CVSAntifungalPenLabel.jpg


Structured Label Content

Warnings

For external use only

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
Purpose

Anti-fungal

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
Section 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use on diaper rash

Active Ingredient

Undecylenic Acid 25%

Questions Or Comments? (Questions or Comments?)

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

Image of Label and Carton

CVSAntifungalPenLabel.jpg


Advanced Ingredient Data


Raw Label Data

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