Dermisa

Manufacturer: Montani Cosmetics Inc
Effective date: 2018-07-19
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 22:56:21

Label at a glance#

ProductDermisa Skin Fade

Active ingredientHYDROQUINONE, PADIMATE O

Label structure8 sections

Dosage and administration

Apply a small amount as a thin layer to the affected areas twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.Lightening effect of this product may not be noticeable when used on very dark skin. Children under 12 years of age: do not use unless directed by a doctor. Indications: For the gradual fading of dark age spots, liver sp...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone USP 2%
Octyl Dimethyl Paba 0.60%

Purpose

OTC - PURPOSE SECTION

Skin Lightener
Sunscreen

Use

INDICATIONS & USAGE SECTION

Lightens dark discolorations in the skin such as age spots, liver spots, freckles, minor scars and pigment in skin that may occur during pregnancy or from the use of oral contraceptives.
Contains a sunscreen to help prevent darkening from reoccurring.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes. Some users of this product may experience a mild skin irritation. If irritation becomes severe, stop use and consult a doctor. Do not use on children under 12 years of age unless directed by a doctor. Sun exposure should be limited by using a sunscreen agent, a sunblocking agent or protective clothing to cover bleached skin after treatment to prevent darkening from recurring. This product is not for the use in the prevention of sunburn

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a small amount as a thin layer to the affected areas twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.Lightening effect of this product may not be noticeable when used on very dark skin. Children under 12 years of age: do not use unless directed by a doctor.
Indications: For the gradual fading of dark age spots, liver spots, freckles and melasma (a condition caused during pregnancy or by the use of oral contraceptives)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glyceryl Monostearate, Mineral Oil, Propylene Glycol, Cetyl Alcohol, Dimethicone, Sodium Lauryl Sulphate, Disodium EDTA, Ascorbic Acid (Vitamin C), Sodium Metabisulphite, Propylparaben, Fragrance, Allantoin

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
153031	hydroquinone 2 % Topical Cream	PSN	5
153031	hydroquinone 20 MG/ML Topical Cream	SCD	5
153031	hydroquinone 2 % Topical Cream	SY	5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
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
68343-001-01	2021-01-29	C162847	48780-1	ba0f9c33-37c8-a910-e053-dadaa90a0b85	Drug Facts
68343-001-02	2021-01-29	C162847	48780-1	ba0f9c33-37c8-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68343-001-01	DermisaSkin Fade	1 in 1 BOX	CREAM	1	5
68343-001-02	DermisaSkin Fade	1 in 1 BOX	CREAM	1	5
68343-001-25	DermisaSkin Fade	25 g in 1 TUBE	CREAM	25	5
68343-001-50	DermisaSkin Fade	50 g in 1 TUBE	CREAM	50	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68343-001	DERMISA SKIN FADE (HYDROQUINONE PADIMATE O) CREAM [MONTANI COSMETICS INC]	5	Legacy NDC, 4 package rows	20180720_03fff226-a013-4a71-926e-5df3661be22e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	3
PADIMATE O	ACTIVE INGREDIENT	Z11006CMUZ	3
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	3
PADIMATE O	ACTIVE MOIETY	Z11006CMUZ	3
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Dermisa Skin Fade
Hydroquinone Padimate O
WATER
MINERAL OIL
GLYCERYL MONOSTEARATE
PROPYLENE GLYCOL
CETYL ALCOHOL
DIMETHICONE
SODIUM LAURYL SULFATE
EDETATE DISODIUM
ASCORBIC ACID
SODIUM METABISULFITE
PROPYLPARABEN
ALLANTOIN
HYDROQUINONE
PADIMATE O

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68343-001	68343-001-50, 68343-001-01, 68343-001-25, 68343-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
MINERAL OIL	T5L8T28FGP	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CETYL ALCOHOL	936JST6JCN	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
ALLANTOIN	344S277G0Z	IACT
HYDROQUINONE	XV74C1N1AE	ACTIB
PADIMATE O	Z11006CMUZ	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 408 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	POWDER, FOR SOLUTION / ORAL		560 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / SUBMUCOSAL	5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / RESPIRATORY (INHALATION)	0.3 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / SUBCUTANEOUS		79 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / SUBMUCOSAL		5 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	CAPSULE, DELAYED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	TABLET, ORALLY DISINTEGRATING / ORAL	2.35 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	CAPSULE / ORAL	0.36 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRALESIONAL	0.1 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, SOLUTION / INTRAVENOUS		4 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	TABLET / ORAL		80 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SYRUP / ORAL		200 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	2 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FILM COATED / ORAL		240 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates

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
71653743-e77e-90b0-e053-2995a90a1e98			03fff226-a013-4a71-926e-5df3661be22e	2018-07-19	Warnings	Exact identifier spl id: 71653743-e77e-90b0-e053-2995a90a1e98 spl set id: 03fff226-a013-4a71-926e-5df3661be22e

Reported adverse events (FAERS/openFDA)#

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