FUNGAL NAIL RENEWAL- undecenoic acid liquid

Fungal Nail Renewal by

Drug Labeling and Warnings

Fungal Nail Renewal by is a Otc medication manufactured, distributed, or labeled by Shengnan (Guangzhou) Cosmetics Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Fungal Nail Renewal

ACTIVE INGREDIENT

Undecenoic Acid 0.5%

PURPOSE

Sterilizing

INDICATIONS & USAGE

RESTORES AND RENEWS
HYDRATES DAMAGED NAILS

WARNINGS

Do not use on children under 2 years of age unless directed by a doctor.
For external use only.
Avoid contact with the eyes.
Keep out of reach of children section.

DO NOT USE

Do not use on children under 2 years of age unless directed by a doctor.

WHEN USING

Avoid contact with eyes or mucous membranes.
Do not apply to wounds or damaged skin.
Do not use with other ointments, creams, sprays or liniments.

STOP USE

If swelling, blistering or other discomfort occurs,please stop using and consult doctor immediately.
If symptoms have not been relieved after using for more than 7 days, please stop using and consult doctor immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children section.

DOSAGE & ADMINISTRATION

Apply two drops each time, 2-3 times a day, do not rinse with cold water within 2 hours after use.

STORAGE AND HANDLING

Store in a cool dry place away from direct sunlight.

INACTIVE INGREDIENT

Glycerin
Propylene Glycol
Otassium Iodide
Menthol
Camellia Sinensis Seed Oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGAL NAIL RENEWAL 
undecenoic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84019-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
11-HYDROXY-2-UNDECENOIC ACID (UNII: UOM92D5748) (11-HYDROXY-2-UNDECENOIC ACID - UNII:UOM92D5748)	11-HYDROXY-2-UNDECENOIC ACID	0.005 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
METAHOMOMENTHOL, (+/-)- (UNII: 73RQD9KEHS)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84019-201-01	1 in 1 BOX	01/25/2024
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 84019-201-02	1 in 1 BOX	01/25/2024
2		20 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 84019-201-03	1 in 1 BOX	01/25/2024
3		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	01/25/2024

Labeler - Shengnan (Guangzhou) Cosmetics Co., LTD (541200425)

Establishment
Name	Address	ID/FEI	Business Operations
Shengnan (Guangzhou) Cosmetics Co., LTD		541200425	manufacture(84019-201)