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

CVS Pharmacy by

Drug Labeling and Warnings

CVS Pharmacy by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Dhaliwal Laboratories,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 DOCTOR

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

DO NOT USE

Do not use on diaper rash

WHEN USING

When using this product avoid contact with the eyes

STOP USE

Stop use and ask doctor if

• irritation occurs
• there is no improvement within 4 weeks

KEEP OUT OF REACH OF CHILDREN

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.jpg

INGREDIENTS AND APPEARANCE

CVS PHARMACY  ANTI-FUNGAL PEN MAXIMUM STRENGTH
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-965
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-965-02	1 in 1 BOX	12/27/2012
1	NDC: 59779-965-01	1.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/27/2012

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Laboratories,LLC		016754201	manufacture(59779-965)