ALPHATIP NAIL REPAIR PEN- nail repair pen liquid

AlphaTip Nail Repair Pen by

Drug Labeling and Warnings

AlphaTip Nail Repair Pen by is a Otc medication manufactured, distributed, or labeled by Guangzhou Qiexiran Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Undecylenic Acid 20%

Purpose

Anti-Fungal

Use

For the treatment of most athlete’s foot (tinea pedis)
For the treatment of ringworm (tinea corporis)
Helps prevent recurrence of these fungal infections

Warnings

Do not use on children under 2 years of age unless directed by a doctor.
Stop use and ask a doctor if irritation occurs or condition persists.
If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

On irritated skin and any area that is infected or reddened.
If pregnant or if there is any allergic reaction to this product.

When Using

Avoid contact with eyes.

Stop Use

If you have diabetes or poor blood circulation

Ask Doctor

If discomfort persists.

Keep Out Of Reach Of Children

If product gets into eyes, flush with water for 15 minutes
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the affected area and dry thoroughly.
Apply a thin layer over affected area twice daily (morning and night).
Use daily for 4 weeks; if condition persists, consult a doctor.

Other information

Skin discoloration may occur during or after use. Protect from excessive heat (above 40°C / 104°F)

Inactive ingredients

Mineral Oil, Ethylene/Propylene/Styrene Copolymer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Commiphora Myrrha Oil, Chrysanthellum Indicum Extract, Phytosteryl Oleate, Lavandula Angustifolia (Lavender) Oil.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALPHATIP NAIL REPAIR PEN 
nail repair pen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85817-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
ETHYLENE (UNII: 91GW059KN7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIHYDROPHYTOSTERYL OCTYLDECANOATE (UNII: T55ULQ060E)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
MINERAL OIL (UNII: T5L8T28FGP)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
COMMIPHORA MYRRHA OIL (UNII: H74221J5J4)
CHRYSANTHELLUM INDICUM WHOLE (UNII: YPX537PA31)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85817-008-01	2 in 1 BOX	11/12/2025
1		3 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	11/12/2025

Labeler - Guangzhou Qiexiran Cosmetics Co., Ltd. (513170495)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Qiexiran Cosmetics Co., Ltd.		513170495	manufacture(85817-008)