FDA.reportPublic FDA data

SEACALL NAIL REVIVE SERUM

Manufacturer
Guangdong Quadrant Ecological Technology Co., Ltd.
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:39:03

Label at a glance#

ProductSEACALL NAIL REVIVE SERUM
Active ingredientSULFUR
Label structure13 sections

Dosage and administration

Take appropriate amount and apply it to the affected area 1-2 times a day for 2-4 weeks.

Storage and handling

If you are using other drugs, please consult your physician or pharmacist before using this product. Shielded from light, sealed, stored in a cool place (not more than 20℃).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 0.5%

Purpose

OTC - PURPOSE SECTION

For Healthier and Stronger Nails.

Use

INDICATIONS & USAGE SECTION

For superficial skin fungal infections, skin candidiasis,onychomycosis.

Warnings

WARNINGS SECTION

· For external use only.
· Contraindicated for children, pregnant and lactating woman.
· Prohibited for those who are allergic to this product. Allergic persons should be cautious.
· Prohibit the use of this product when the properties of the product have changed.

Do not use

OTC - DO NOT USE SECTION

Do not use if there is any burning sensation, redness or swelling at the site of application.

When Using

OTC - WHEN USING SECTION

When Using this product: avoid contact with eyes, nose and mouth. If contact occurs, rinse thoroghly with water.

Stop Use

OTC - STOP USE SECTION

Stop Using and ask a doctor if irritation or redness develops and lasts.

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop Using and ask a doctor if irritation or redness develops and lasts.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children. In cacse of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Take appropriate amount and apply it to the affected area 1-2 times a day for 2-4 weeks.

Other information

STORAGE AND HANDLING SECTION

If you are using other drugs, please consult your physician or pharmacist before using this product.
Shielded from light, sealed, stored in a cool place (not more than 20℃).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Water, Propylene Glycol, Zinc Oxide, Petrolatum, Cera Alba, Cera Microcristallina, Lanolin, Cyclopentasi loxane, Polyglyceryl-3 Diisostearate, Ozokerite, Tridecyl Trimellitate, Cyclohexasiloxane, Polyglyceryl-10 Dioleate, Methylparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2690882sulfur 0.5 % Topical CreamPSN3
2690882sulfur 5 MG/ML Topical CreamSCD3
2690882sulfur 0.5 % Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-002-01SEACALL NAIL REVIVE SERUM20 g in 1 TUBECREAM203

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76986-00276986-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHITE WAX7G1J5DA97FIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
LANOLIN7EV65EAW6HIACT
SULFUR70FD1KFU70ACTIB
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ZINC OXIDESOI2LOH54ZIACT
ETHYLENE DISTEARAMIDE603RP8TB9AIACT
CYCLOMETHICONE 50THT5PCI0RIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
CERESINQ1LS2UJO3AIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
METHYLPARABENA2I8C7HI9TIACT
POLYGLYCERYL-10 DIOLEATE598RES7AXXIACT
CYCLOMETHICONE 6XHK3U310BAIACT

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
SEACALL NAIL REVIVE SERUMNAIL REVIVE SERUMGuangdong Quadrant Ecological Technology Co., Ltd.1f4d0c9a-361e-72e5-e063-6394a90a7cda2025-10-15WarningsExact identifier
ndc (package): 76986-002-01
ndc (product): 76986-002
ndc11 (package): 76986000201
spl id: 412fb69b-a8d6-f89d-e063-6394a90a6201
spl set id: 1f4d0c9a-361e-72e5-e063-6394a90a7cda

Reported adverse events (FAERS/openFDA)#

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