NAIL REPAIR PEN- undecylenic acid liquid

NAIL REPAIR PEN by

Drug Labeling and Warnings

NAIL REPAIR PEN by is a Otc medication manufactured, distributed, or labeled by Yunqi Cosmetics (Shenzhen) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Undecylenic Acid 25%

PURPOSE

Antifungal

INDICATIONS & USAGE

Mainly used to control and reduce nail fungus issues, and improve discoloration, thickening, layering, cracking
brittleness, and ingrown nails.

WARNINGS

For external use only.

DO NOT USE

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

WHEN USING

When using this product avoid contact with eyes.
Pregnant women, people with sensitive skin, or children should consult a professional before use.

STOP USE

Stop use and ask a doctor lf irritation occurs or if there is no improvement within 2 weeks.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Read all warnings and directions ·Use only as directed
Clean the affected area with soap and water and dry thoroughly
Remove cap from pen .Twist the base of the pen, with brush pointing downward, until product dispenses
Apply a thin laver 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; wear well-ftting, ventilated shoe. and change shoes and socks at least once daily.

INACTIVE INGREDIENT

Aloe Vera Extract
Sweet Almond Oil
Jojoba Oil
Tea Tree Oil
Manuka Oil
Clove Bud Oil
Lavender Oil
Oregano Oil
Peppermint Oil
Pine Oil
Olive Fruit Oil
Flaxseed Oil
Borage Seed Oil
Leptospermum Petersonii Leaf Oil
Propolis Extract
Tocopheryl Acetate (Vitamin E)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAIL REPAIR PEN 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84763-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	0.25 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OLIVE OIL (UNII: 6UYK2W1W1E)
WHITE PINE OIL (UNII: HA5CX6676U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
BORAGE SEED OIL (UNII: F8XAG1755S)
JOJOBA OIL (UNII: 724GKU717M)
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)
ALMOND OIL (UNII: 66YXD4DKO9)
MANUKA OIL (UNII: M6QU9ZUH2X)
CLOVE OIL (UNII: 578389D6D0)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
PEPPERMINT OIL (UNII: AV092KU4JH)
LINSEED OIL (UNII: 84XB4DV00W)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84763-008-01	8 in 1 BOX	12/09/2025
1		24 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 84763-008-02	4 in 1 BOX	12/09/2025
2		12 mL in 1 TUBE, WITH APPLICATOR; 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	12/09/2025

Labeler - Yunqi Cosmetics (Shenzhen) Co., Ltd (978129337)

Establishment
Name	Address	ID/FEI	Business Operations
Yunqi Cosmetics (Shenzhen) Co., Ltd		978129337	manufacture(84763-008)