Derma Lightening

Manufacturer: Pella Pharmaceuticals Co. Ltd
Effective date: 2021-12-01
Label type: HUMAN OTC DRUG LABEL
Version: 412
Source: full-release
Hydrated at: 2026-05-31 23:45:32

Label at a glance#

ProductDerma Lightening

Active ingredientHYDROQUINONE, TRETINOIN

Label structure14 sections

Dosage and administration

Apply the cream once daily at night after cleansing. Then rub it gently.

Storage and handling

Store at a temperature be]ow 30 °C. Do not store after a month from opening the tube.

Label contents#

Full prescribing information#

Forms and Presentation

HOW SUPPLIED SECTION

Cream: Tube of 30 g.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Tretinoin 0.025%

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Cetyl Alcohol, Ceteareth- 25, Cetearyl Alcohol, Caprylic / Capric Triglyceride, Dimethicone, Stearic Acid, Petrolatum, Benzyl Alcohol, Sodium Lauryl Sulphate, Potassium Sorbate, Sodium Metabisulfite, Parfum and BHA

Purpose

OTC - PURPOSE SECTION

Lightening Cream

Properties

DESCRIPTION SECTION

Night cream that lightens and moisturizes the skin.
Paraben free.

Indications

INDICATIONS & USAGE SECTION

Whitening of skin.
Reduction of spots due to sunlight exposure.
Pregnancy Mask (Melasma). (Use after pregnancy)
Reduction of secular pigmentations of acne.
Can be used on knees and elbows.

Precaution

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

Warnings

WARNINGS SECTION

For external use only
Avoid contact with eyes
Do not expose to sunlight and wear protective clothing

Contraindications

CONTRAINDICATIONS SECTION

Hypersensitivity to any of the components.

Side effects

ADVERSE REACTIONS SECTION

There are no known side effects.

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Apply the cream once daily at night after cleansing. Then rub it gently.

Storage conditions

STORAGE AND HANDLING SECTION

Store at a temperature be]ow 30 °C.
Do not store after a month from opening the tube.

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary Package

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
HYDROQUINONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
TRETINOIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60	Product name	6	20251124
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ec	Product name	2	20250521
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
503b047e-e62d-4745-9011-522b13bc701b	Product name	1	20181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4	Product name	2	20170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572	Product name	2	20150818
0a8118e4-08c6-b395-9ddc-d3e425e0493a	Product name	1	20140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579	Product name	1	20140508
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82160-412-01	2023-01-30	C162847	48780-1	f386c64a-3447-0266-e053-dadaa90a7c1a	Lightening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82160-412-01	Derma Lightening	30 g in 1 TUBE	CREAM	30		412
82160-412-01	Derma Lightening	1 in 1 CARTON	CREAM	1		412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82160-412	DERMA LIGHTENING (HYDROQUINONE, TRETINOIN) CREAM [PELLA PHARMACEUTICALS CO. LTD]	412	Legacy NDC, 2 package rows	20211209_d215bd97-a589-ccbf-e053-2995a90adaa2.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Derma Lightening
Hydroquinone, Tretinoin
MEDIUM-CHAIN TRIGLYCERIDES
POTASSIUM SORBATE
BUTYLATED HYDROXYANISOLE
DIMETHICONE 100
STEARIC ACID
SODIUM METABISULFITE
BENZYL ALCOHOL
SODIUM LAURYL SULFATE
PETROLATUM
HYDROQUINONE
TRETINOIN
WATER
GLYCERIN
CETYL ALCOHOL
CETEARETH-25
CETOSTEARYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82160-412	82160-412-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
BUTYLATED HYDROXYANISOLE	REK4960K2U	IACT
DIMETHICONE 100	RO266O364U	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
PETROLATUM	4T6H12BN9U	IACT
HYDROQUINONE	XV74C1N1AE	ACTIB
TRETINOIN	5688UTC01R	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CETEARETH-25	8FA93U5T67	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d215bd97-a58a-ccbf-e053-2995a90adaa2			d215bd97-a589-ccbf-e053-2995a90adaa2	2021-12-01	Warnings, Adverse reactions	Exact identifier spl id: d215bd97-a58a-ccbf-e053-2995a90adaa2 spl set id: d215bd97-a589-ccbf-e053-2995a90adaa2

Reported adverse events (FAERS/openFDA)#

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