FUNGAL NAIL RENEWAL- undecylenic acid 25% fungal nail renewal liquid

FUNGAL NAIL RENEWAL by

Drug Labeling and Warnings

FUNGAL NAIL RENEWAL by is a Otc medication manufactured, distributed, or labeled by Medhome Pharma Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Undecylenic acid 25%

PURPOSE

Antifungal

USE IN SPECIFIC POPULATIONS

Use

Cures most Athlete's Foot (Tinea Pedis)
and Ringworm (Tinea Corporis). Relieves
itching, scaling, cracking, burning,
redness, sorenes, and irritation and
discomfort. Helps prevent most athlete's
foot (dermatophytosis) with daily use.

WARNINGS

For external use only.

DO NOT USE

on children under 2 years
of age unless directed by a doctor.

WHEN USING

avoid contact with eyes.

STOP USE

irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

ASK DOCTOR

irritation occurs, there is no improvement
within 4 weeks (for athlete's foot and
ringworm).

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

For athlete's foot and ringworm: use daily for 4 weeks.

Clean theaffected area and dry thoroughly.

Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.

Supervise children in the use of this product.

This product is not effective for the treatment of ringworm of the scalp or nails.

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.

To prevent athlete's foot, apply once or twice daily (morning and/or night).

Apply to skin around the nail and cuticle.

INFORMATION FOR PATIENTS

Store at room temperature 15-30℃ (59-86℉)

INACTIVE INGREDIENT

water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.

DOSAGE & ADMINISTRATION

30ml/1OZ

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGAL NAIL RENEWAL 
undecylenic acid 25% fungal nail renewal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84007-130
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
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRACRYLIC ACID (UNII: C4ZF6XLD2X)
WATER (UNII: 059QF0KO0R)
EUPHORBIA HIRTA WHOLE (UNII: L13YF113GN)
RESORCINOL (UNII: YUL4LO94HK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84007-130-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/30/2025

Labeler - Medhome Pharma Inc (129936136)

Registrant - Medhome Pharma Inc (129936136)