AlphaTip Nail Repair Pen

Manufacturer
Guangzhou Qiexiran Cosmetics Co., Ltd.
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:30

Label at a glance#

ProductAlphaTip Nail Repair Pen
Active ingredientUNDECYLENIC ACID
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 20%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

Avoid contact with eyes.

Stop Use

OTC - STOP USE SECTION

If you have diabetes or poor blood circulation

Ask Doctor

OTC - ASK DOCTOR SECTION

If discomfort persists.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1437295undecylenic acid 20 % Topical SolutionPSN1
1437295undecylenic acid 200 MG/ML Topical SolutionSCD1
1437295undecylenic acid 20 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85817-008-01AlphaTip Nail Repair Pen3 mL in 1 TUBE, WITH APPLICATORLIQUID31
85817-008-01AlphaTip Nail Repair Pen2 in 1 BOXLIQUID21

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85817-00885817-008-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlphaTip Nail Repair PenNAIL REPAIR PENGuangzhou Qiexiran Cosmetics Co., Ltd.435c7973-8a67-8f51-e063-6394a90af58f2025-11-11WarningsExact identifier
ndc (package): 85817-008-01
ndc (product): 85817-008
ndc11 (package): 85817000801
spl id: 435c7973-8a68-8f51-e063-6394a90af58f
spl set id: 435c7973-8a67-8f51-e063-6394a90af58f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.