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ALWAYS BRIGHT SPOT LUMEDIC

Medically reviewed on March 19, 2018

Dosage form: cream
Ingredients: Glycerin 12.8g in 100mL, Niacinamide 2.0g in 100mL
Labeler: DMS INTERNATIONAL CO., LTD.
NDC Code: 70265-170

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

Active Ingredient: Glycerin 12.84%, Niacinamide 2.00%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Glycereth-26, Limnanthes Alba (Meadowfoam) Seed Oil, Hydrogenated Vegetable Oil, Cetearyl Alcohol, Mangifera Indica (Mango) Seed Butter, Caprylic/Capric Triglyceride, Trehalose, Glyceryl Stearate, PEG-40 Stearate, Stearic Acid , Cyclopentasiloxane, Glycol Stearate SE, Camellia Oleifera Seed Oil, Hydrogenated Lecithin, Palmitic Acid, Cyclohexasiloxane, Dimethicone, Malpighia Emarginata (Acerola) Fruit Extract, Caprylyl Glycol, Houttuynia Cordata Extract, PEG-100 Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Alcohol, Ethylhexylglycerin, Sorbitan Stearate, Glyceryl Polymethacrylate, Allantoin, Phenoxyethanol, 1,2-Hexanediol, Propylene Glycol, Sodium Hyaluronate, Disodium EDTA, Triethanolamine, Aleuritic Acid, Yeast Extract, Sutilains, Glycoproteins, Lecithin, Panthenol, Potassium sorbate, Methylparaben, Tocopheryl Acetate, Ethylparaben, Butylparaben, Isobutylparaben, Ceramide 3, Dextran, Propylparaben, BHT, Isopropylparaben, Sodium Ascorbyl Phosphate, Nonapeptide-1, Biotin

PURPOSE

Purpose: Skin protectant

WARNINGS

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

KEEP OUT OF REACH OF CHILDREN

Keep product out of reach of infants and children.

INDICATIONS & USAGE

Indications & usage: At daily skin care, get a proper amount it and apply evenly on the whole face. Absorb it by tapping softly with end of finger up.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use immediately after opening.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALWAYS BRIGHT SPOT LUMEDIC 
glycerin, niacinamide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70265-170
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (GLYCERIN) Glycerin12.8 g  in 100 mL
Niacinamide (NIACINAMIDE) Niacinamide2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Butylene Glycol 
Packaging
#Item CodePackage Description
1NDC:70265-170-01100 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2016
Labeler - DMS INTERNATIONAL CO., LTD. (688309194)
Registrant - DMS INTERNATIONAL CO., LTD. (688309194)
Establishment
NameAddressID/FEIOperations
DMS INTERNATIONAL CO., LTD.688309194repack(70265-170)
Establishment
NameAddressID/FEIOperations
Cosmecca Korea Co., Ltd.688830827manufacture(70265-170)

 
DMS INTERNATIONAL CO., LTD.

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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