SKINMD LABORATORIES PURE WHITENOL SERUM

Manufacturer
Reviresco Co., Ltd. | Cosmax, Inc.
Effective date
2019-12-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:18

Label at a glance#

ProductSKINMD LABORATORIES PURE WHITENOL SERUM
Active ingredientTranexamic acid
Label structure8 sections

Indications and uses

Uses: For skin Whitening

Dosage and administration

Directions: Apply two times at morning and night onto the skin daily.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Tranexamic acid 0.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water,Butylene Glycol,Glycerin, Octyldodecyl Myristate,Hydrogenated Poly(C6-14 Olefin), Limnanthes Alba (Meadowfoam) Seed Oil, Mineral Oil, Borago Officinalis Seed Oil, Rhodiola Sachalinensis Extract, Morus Alba Root Extract, Pentylene Glycol, Polysorbate 60, Glyceryl Stearate SE, Stearic Acid, Hydroxypropyl Bispalmitamide MEA, Cyclopentasiloxane, Dimethicone, Sorbitan Sesquioleate, Sorbitan Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Dextrin, Lecithin, Isohexadecane, Caprylyl Glycol, Tocopheryl Acetate, 4-Butylresorcinol, Trehalose, Arginine, Polysorbate 80, Squalane, Sodium Hyaluronate, Cetearyl Alcohol, Carbomer, BHT, Disodium EDTA, Fragrance(Parfum)

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Whitening

WARNINGS

WARNINGS SECTION

Warnings:

1. Discontinue use if the following symptoms occur. If symptoms are extreme consult a dermatologist. 1) Symptoms such as red dots, swollenness, itching, stimulation during use. 2) Symptoms such as the ones mentioned in 1) occur on the applied area. 2. Do not apply to parts of the skin that have rashes, are cut, or are infected. 3. Directions for storage and handling. 1) The lid must be closed after use. 2) Keep out of reach of babies and children. 3) Store in a cool and dry place and avoid exposure to direct sunlight.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of babies and children.

Uses

INDICATIONS & USAGE SECTION

Uses: For skin Whitening

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Apply two times at morning and night onto the skin daily.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TRANEXAMIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809414000017GTIN-13: 8809414000017
EAN-13: 8809414000017
GTIN storage (14 digits): 08809414000017
pure white carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71974-030-022022-01-28C16284748780-1d6a99b39-d2e9-a426-e053-dadaa90af4c2e451eac7-c186-4df2-a1e4-1bfd3dcef557

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71974-030-01SKINMD LABORATORIES PURE WHITENOL SERUM50 mL in 1 BOTTLE, PUMPCREAM502
71974-030-02SKINMD LABORATORIES PURE WHITENOL SERUM1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71974-030SKINMD LABORATORIES PURE WHITENOL SERUM (TRANEXAMIC ACID) CREAM [REVIRESCO CO., LTD.]2Legacy NDC, 2 package rows20191224_e451eac7-c186-4df2-a1e4-1bfd3dcef557.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71974-03071974-030-01, 71974-030-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Tranexamic acid6T84R30KC1ACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

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
e919934e-1eb4-4d6d-a717-480086f40519e451eac7-c186-4df2-a1e4-1bfd3dcef5572019-12-24WarningsExact identifier
spl id: e919934e-1eb4-4d6d-a717-480086f40519
spl set id: e451eac7-c186-4df2-a1e4-1bfd3dcef557

Reported adverse events (FAERS/openFDA)#

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