ANTI-FUNGAL PEN CVS- undecylenic acid liquid

Anti-Fungal Pen by

Drug Labeling and Warnings

Anti-Fungal Pen by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                          Purpose

Undecylenic Acid 25%..................Anti-fungal

PURPOSE

Uses

For the cure of most ringworm (tinea corporis) athlete’s foot (tinea pedis) For the relief of: itching scaling cracking
burning redness soreness irritation and discomforts which may accompany these conditions

WARNINGS

Warnings
For external use only.
Ask a doctor before use on children under 2 years of age
When using this product avoid contact with eyes
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 immediately.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Inactive ingredients : Isopropyl Palmitate, Propylparaben

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI-FUNGAL PEN  CVS
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-835
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Undecylenic Acid (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	Undecylenic Acid	25 g  in 100 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: 59779-835-01	1 in 1 CARTON	09/15/2016
1		1.7 mL in 1 CONTAINER; 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	09/15/2016

Labeler - CVS (062312574)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(59779-835) , label(59779-835)