FDA.reportPublic FDA data

Medisilke NIGHT CREAM

Manufacturer
New GPC, Inc.
Effective date
2010-10-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:52:12

Label at a glance#

ProductMedisilke Night
Active ingredientHYDROQUINONE
Label structure9 sections

Indications and uses

For the gradual fading of brownish spots.

Dosage and administration

Adults: apply a small amount as a thin layer on the affected area twice daily to affected area or use as directed by a physician. If no improvement is seen after 3 months of treatment, use of this product should 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Purpose

OTC - PURPOSE SECTION

Skin bleaching agent.

Uses

INDICATIONS & USAGE SECTION

For the gradual fading of brownish spots.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, SD Alcohol 40, Glyceryl Stearyl Citrate, Butylene Glycol, Ethylhexyl Palmitate, Methylpropanediol, Behenyl Alcohol, Glycerin,Sodium Hyaluronate, Disodium EDTA, Xanthan Gum, HydroxyethylCellulose, Cetearyl Alcohol, Cetearate-20, BHT, Glyceryl Dilaurate, Dimethicone, Hydroxyethyl Acrylate,Sodium AcryloylDimethyl Taurate Copolymer, Squalane, Polysorbate 60, Bambusa Vulgaris Leaf/Stem Extract, Pisum Sativum(Pea) Extract, Glucosamine HCl, Pyrus Malus (Apple) Fruit Extract, Glycine Soja (Soybean) Seed Extract, Retinol, Allyl Methacrylate Crosspolymer, Polysorbate 20, Camellia Sinensis Leaf Extract, EthylHexylglycerin, Methylisothiazolinone, Phenoxyethanol Capryl Glycol, Potassium Sorbate, Hexylene glycol, Glycyrrhiza Glabra (licorice) Root Extract. Citric Acid Tocopheryl Acetate, Caprylic/Capric Triglyceride, Macadamia Ternifola Seed Oil Retinyl Palmitate, Zea Mays (Corn Oil, Ubiquinone, Palmitic Acid, Thioctic Acid, Beta-Carotene, Heluanthus Annus (Sunflower) Seed Oil.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults: apply a small amount as a thin layer on the affected area twice daily to affected area or use as directed by a physician. If no improvement is seen after 3 months of treatment, use of this product should 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.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with eyes.

Some users of this product may experience a mild skin irritation.

OTC - STOP USE SECTION

If skin irritation becomes severe, stop use and consult a physician.

OTC - DO NOT USE SECTION

Do not use on children under 12 years age unless directed by a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a posion control center.

Questions or Comments?

OTC - QUESTIONS SECTION

Moss Pharmaceuticals, P.O. Box 1426, Port Washington, NY 11060.
www.Medisilke.com

SPL UNCLASSIFIED SECTION

Manufactured by: NEW GPC INC., A1 Farm, EBD, Guyana under license for Moss Pharmaceuticals LLC, USA.

PRINCIPAL DISPLAY PANEL - 20g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medisilke
NIGHT CREAM
Skin lightening cream / fades brown spots and skin discoloration

20g

PRINCIPAL DISPLAY PANEL - 20g Tube Carton
PRINCIPAL DISPLAY PANEL - 20g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65588-2230-32019-10-29C16284748780-1960f7f55-c419-8e05-e053-dbdaa90a074aMedisilke NIGHT CREAM

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65588-2230MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]1Legacy NDC20101029_2e53471e-ad03-4d6b-9384-4af374bb5f74.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AE1
HYDROQUINONEACTIVE MOIETYXV74C1N1AE1
ALPHA LIPOIC ACIDINACTIVE INGREDIENT73Y7P0K73Y1
APPLEINACTIVE INGREDIENTB423VGH5S91
BAMBUSA VULGARIS LEAFINACTIVE INGREDIENTEMY54R518C1
BAMBUSA VULGARIS STEMINACTIVE INGREDIENTSMR633LHTC1
BETA CAROTENEINACTIVE INGREDIENT01YAE03M7J1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
CORN OILINACTIVE INGREDIENT8470G57WFM1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933091
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A0651
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
HELIANTHUS ANNUUSINACTIVE INGREDIENTBKJ0J3D1BP1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
MACADAMIA OILINACTIVE INGREDIENT515610SU8C1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
METHYLPROPANEDIOLINACTIVE INGREDIENTN8F53B3R4R1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H11
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
RETINOLINACTIVE INGREDIENTG2SH0XKK911
SOYBEANINACTIVE INGREDIENTL7HT8F1ZOD1
SQUALANEINACTIVE INGREDIENTGW89575KF91
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M461
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65588-223065588-2230-3

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROQUINONEXV74C1N1AEACTIB
WATER059QF0KO0RIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYLHEXYL PALMITATE2865993309IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
DOCOSANOL9G1OE216XYIACT
GLYCERINPDC6A3C0OXIACT
HYALURONATE SODIUMYSE9PPT4THIACT
EDETATE DISODIUM7FLD91C86KIACT
XANTHAN GUMTTV12P4NEEIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
DIMETHICONE92RU3N3Y1OIACT
SQUALANEGW89575KF9IACT
POLYSORBATE 60CAL22UVI4MIACT
BAMBUSA VULGARIS LEAFEMY54R518CIACT
BAMBUSA VULGARIS STEMSMR633LHTCIACT
APPLEB423VGH5S9IACT
SOYBEANL7HT8F1ZODIACT
POLYSORBATE 207T1F30V5YHIACT
RETINOLG2SH0XKK91IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MACADAMIA OIL515610SU8CIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CORN OIL8470G57WFMIACT
UBIDECARENONEEJ27X76M46IACT
PALMITIC ACID2V16EO95H1IACT
ALPHA LIPOIC ACID73Y7P0K73YIACT
BETA CAROTENE01YAE03M7JIACT
HELIANTHUS ANNUUSBKJ0J3D1BPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT

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 8 · 436 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYSUSPENSION / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
SOYBEANSOYBEANL7HT8F1ZODCAPSULE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / TOPICAL3.7 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION / ORAL2.5 ml/5mlExact identifier — unii candidate
11 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii candidate
4 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYAEROSOL / TOPICAL5.5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYGEL / TOPICAL2 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii candidate
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b04435ae-1f67-4bc6-ad07-eceb51ea3d372e53471e-ad03-4d6b-9384-4af374bb5f742010-10-13WarningsExact identifier
spl id: b04435ae-1f67-4bc6-ad07-eceb51ea3d37
spl set id: 2e53471e-ad03-4d6b-9384-4af374bb5f74

Reported adverse events (FAERS/openFDA)#

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