Premier Value® Maximum Strength Antifungal Liquid Solution

Drug Facts

Composition & Product

Active Ingredients

Undecylenic Acid (25 mg)

Inactive Ingredients

Isopropyl Palmitate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-04-10

Medication Information

Purpose

Anti-fungal

Description

Undecylenic Acid 25%

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

Questions?

Call 1-866-467-2748

purpose

Anti-fungal

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.

active Ingredient

Undecylenic Acid 25%

inactive Ingredient

Isopropyl palmitate

Ask A Doctor Before Use

On children under 2 years of age

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 Fungi Cure®

When Using This Product

avoid contact with eyes

Keep Out of Reach of Children.

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

Stop Use and Consult A Doctor If

▪
irritation occurs
▪
there is no improvement within 4 weeks

Structured Label Content

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

Questions?

Call 1-866-467-2748

purpose (Purpose)

Anti-fungal

directions (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 (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.

active Ingredient (Active ingredient)

Undecylenic Acid 25%

inactive Ingredient (Inactive ingredient)

Isopropyl palmitate

Ask A Doctor Before Use (Ask a doctor before use)

On children under 2 years of age

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 Fungi Cure®

When Using This Product (When using this product)

avoid contact with eyes

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

▪
irritation occurs
▪
there is no improvement within 4 weeks

Advanced Ingredient Data

[{"name": "UNDECYLENIC ACID", "unii": "K3D86KJ24N", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ISOPROPYL PALMITATE", "unii": "8CRQ2TH63M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Questions?": "Call 1-866-467-2748", "Purpose": "Anti-fungal", "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.", "Active ingredient": "Undecylenic Acid 25%", "Inactive ingredient": "Isopropyl palmitate", "Ask a doctor before use": "On children under 2 years of age", "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 Fungi Cure®", "When using this product": "avoid contact with eyes", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control right away at 1-800-222-1222.", "Stop use and consult a doctor if": "▪ irritation occurs ▪ there is no improvement within 4 weeks"}

Premier Value® Maximum Strength Antifungal Liquid Solution

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information