Medisilke Night

Dosage form: cream
Ingredients: HYDROQUINONE 2g in 100g
Labeler: New GPC, Inc.
NDC Code: 65588-2230

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Medisilke
NIGHT CREAM

Active Ingredient

Hydroquinone 2%

Purpose

Skin bleaching agent.

Uses

For the gradual fading of brownish spots.

Inactive Ingredients

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

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

For external use only.

Avoid contact with eyes.

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

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

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

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

Questions or Comments?

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

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

PRINCIPAL DISPLAY PANEL - 20g Tube Carton

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

20g

MEDISILKE   NIGHT
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65588-2230
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERYL STEARATE CITRATE 
BUTYLENE GLYCOL 
ETHYLHEXYL PALMITATE 
METHYLPROPANEDIOL 
DOCOSANOL 
GLYCERIN 
HYALURONATE SODIUM 
EDETATE DISODIUM 
XANTHAN GUM 
CETOSTEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
BUTYLATED HYDROXYTOLUENE 
DIMETHICONE 
SQUALANE 
POLYSORBATE 60 
BAMBUSA VULGARIS LEAF 
BAMBUSA VULGARIS STEM 
APPLE 
SOYBEAN 
POLYSORBATE 20 
RETINOL 
MEDIUM-CHAIN TRIGLYCERIDES 
MACADAMIA OIL 
VITAMIN A PALMITATE 
CORN OIL 
UBIDECARENONE 
PALMITIC ACID 
ALPHA LIPOIC ACID 
BETA CAROTENE 
HELIANTHUS ANNUUS 
ETHYLHEXYLGLYCERIN 
METHYLISOTHIAZOLINONE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
POTASSIUM SORBATE 
HEXYLENE GLYCOL 
GREEN TEA LEAF 
GLYCYRRHIZA GLABRA 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:65588-2230-31 TUBE (TUBE) in 1 CARTON
120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A12/01/2009
Labeler - New GPC, Inc. (895025443)
Establishment
NameAddressID/FEIOperations
New GPC, Inc.895025443MANUFACTURE

Revised: 10/2010
 
New GPC, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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