Derma Pella Intimate Brightening

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:21

Label at a glance#

ProductDerma Pella Intimate Brightening
Active ingredientALPHA-ARBUTIN
Label structure14 sections

Dosage and administration

Cleanse area with soap and water, and then gently exfoliate it with a loofah or sponge. This helps to remove any dead skin at the surface and allow the product to contact the fresh area that you want to whiten. Rinse the area and pat dry. Apply a small amount to fingertips and massage gently into the desired area that you are whitening. Allow time for it to absorb. After a few minutes, massage any excess cream int...

Storage and handling

Store below 30 ◦ C.

Label contents#

Full prescribing information#

Form and Presentation

HOW SUPPLIED SECTION

Cream: Plastic Tube, 40 g

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alpha Arbutin

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Polyacrylamide, Phenoxyethanol, Glycerin, C13-14 Isoparaffin, Niacinamide (Vitamin B3), Glycyrrhiza Glabra (Licorice) Root Extract, Hyaluronic Acid, Laureth-7, Ethylhexylglycerin, Citric Acid, Parfum, Benzoic Acid, Dehydroacetic Acid.

Purpose

OTC - PURPOSE SECTION

Whitening Cream for Sensitive Area

Properties

DESCRIPTION SECTION

This product is formulated for use on all skin types and applicable to sensitive, intimate areas.

- Lightens, protects and rejuvenate the skin.
- Brings back the elasticity of the skin.
- Moisture the delicate skin.
- Soothes the skin in a pleasure way.
- Leaves a long-lasting refreshing aroma.

Paraben free

Indication

INDICATIONS & USAGE SECTION

Intimate area brightening cream for women and men.

Precautions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Warnings

WARNINGS SECTION

- For external use only.
- Over application will not increase results.
- If you have a sensitive skin test in a small area in the underarm before using on all your intimate areas.
- Discontinue if excessive redness or irritation occurs. If irritation persists, consult with a physician or pharmacist.
- Avoid direct contact with eyes, if contact occurs, rinse thoroughly with water.
- Do not apply to open wounds or mucous membranes.

Contraindications

CONTRAINDICATIONS SECTION

Hypersensitivity to any of the components.

Side effects

ADVERSE REACTIONS SECTION

It is well tolerated product there are no known side effects.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Cleanse area with soap and water, and then gently exfoliate it with a loofah or sponge. This helps to remove any dead skin at the surface and allow the product to contact the fresh area that you want to whiten. Rinse the area and pat dry. Apply a small amount to fingertips and massage gently into the desired area that you are whitening. Allow time for it to absorb. After a few minutes, massage any excess cream into the area. Only use enough cream to apply a thin layer. Apply twice daily for maximum effectiveness.

Storage Conditions

STORAGE AND HANDLING SECTION

Store below 30 ◦C.

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-818-01Derma Pella Intimate Brightening1 in 1 CARTONCREAM12
82160-818-01Derma Pella Intimate Brightening40 g in 1 TUBECREAM402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-818DERMA PELLA INTIMATE BRIGHTENING (ALPHA ARBUTIN) CREAM [PELLA PHARMACEUTICALS CO. LTD]22 package rows20250101_feb200b9-00ee-2e29-e053-6394a90a1848.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-81882160-818-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
2a913e5c-46c2-2bdb-e063-6394a90a0264feb200b9-00ee-2e29-e053-6394a90a18482024-12-31Warnings, Adverse reactionsExact identifier
spl id: 2a913e5c-46c2-2bdb-e063-6394a90a0264
spl set id: feb200b9-00ee-2e29-e053-6394a90a1848

Reported adverse events (FAERS/openFDA)#

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