CVS MAXIMUM STRENGTH ANTI-FUNGAL PEN 25%- undecylenic acid liquid

CVS Maximum Strength Anti-Fungal Pen 25% by

Drug Labeling and Warnings

CVS Maximum Strength Anti-Fungal Pen 25% by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Undecylenic acid 25%

PURPOSE

Purpose

Anti-fungal

INDICATIONS & USAGE

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

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 OF REACH OF CHILDREN

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

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, 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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

Inactive ingredient

Isopropyl Palmitate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS MAXIMUM STRENGTH ANTI-FUNGAL PEN 25% 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9008
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 mg  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9008-16	3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/09/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-9008)