PREMIER VALUE ANTIFUNGAL MAXIMUM STRENGTH- undecylenic acid liquid

Premier Value Antifungal by

Drug Labeling and Warnings

Premier Value Antifungal by is a Otc medication manufactured, distributed, or labeled by PHARMACY VALUE ALLIANCE, 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)
• ▪ itching
• ▪ scaling
• ▪ cracking
• ▪ burning
• ▪ redness
• ▪ soreness
• ▪ irritation
• ▪ discomfort

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 eyes

Stop use and consult a doctor if

• ▪ irritation occurs
• ▪ there is no improvement within 4 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control right away at 1-800-222-1222.

​Directions

Read all warnings and directions.

• ▪ Read all package directions and warnings before use
• ▪ Use only as directed
• ▪ clean the affected area with soap and warm water and dry thoroughly
• ▪ Apply a thin layer of this product over affected area twice daily (morning and night) or as directed by a doctor.
• ▪ The brush applicator allows for easy application under nails and surrounding cuticle area.
• ▪ wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• ▪ this product is not effective on the scalp or nails
• ▪ for athlete's foot: pay special attention to spaces between 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 conditions 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

Other information

• This product may be applied to exposed nail-beds to cuticles, around nail edges and under nail tips where reachable with its applicator brush
• This product is not intended to, nor will it, penetrate hard nail surfaces
• While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use this product until satisfactory results are obtained.
• store at room temperature. Keep the container tightly closed when not in use.
• Store away from excessive heat and cold.

​Inactive ingredient

Isopropyl palmitate

Questions?

Call 1-866-467-2748

Principal Display Panel

NDC: 68016-474-00

COMPARE TO THE ACTIVE INGREDIENT FUNGICURE®

MAXIMUM STRENGTH
Anti-Fungal Liquid

• Topical formula for toe and foot
• Cures and Heals athlete’s foot fungus and ringworm
• Helps relieves related discomforts

1 FL OZ (30mL)

IMPORTANT: KEEP this carton for future reference on full labeling

DISTRIBUTED BY

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by ALVA-AMCO Pharmacal Cos., Inc., the distributor of Funji Cure®

INGREDIENTS AND APPEARANCE

PREMIER VALUE ANTIFUNGAL  MAXIMUM STRENGTH
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-474
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 30 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-474-00	30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	04/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/10/2019

Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)