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Gem Miracle Black Pearl O2 Whitening

Medically reviewed on December 29, 2017

Dosage form: cream
Ingredients: Niacinamide 1.20g in 60mL
Labeler: The Saem International Co., Ltd.
NDC Code: 70341-330

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 Ingredients: Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Cetearyl Olivate, Sorbitan Olivate, Butylene Glycol, Hydrogenated Polyisobutene, Cyclopentasiloxane, Cyclohexasiloxane, Macadamia Ternifolia Seed Oil, Diethylhexyl Carbonate, Cetyl Alcohol, Pentylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Portulaca Oleracea Extract, Phenoxyethanol, Carbomer, Chlorphenesin, Potassium Hydroxide, Lepidium Sativum Sprout Extract, Lecithin, Soy Iso avones, Polysorbate 80, Alcohol, 1,2-Hexanediol, Disodium EDTA, Hydrolyzed Conchiolin Protein, Propylene Glycol, Oyster Shell Extract, Sea Silt Extract, Soluble Collagen, Laminaria Saccharina Extract, Plankton Extract, Laminaria Digitata Extract, Cocos Nucifera (Coconut) Oil, Gardenia Tahitensis Flower, Tocopherol, Maris Aqua, Morinda Citrifolia Extract, Sodium Hyaluronate, Propanediol, Asparagus O cinalis Stem Extract, Sodium Benzoate, Potassium Sorbate, Gluconolactone, Calcium Gluconate, Calophyllum Inophyllum Seed Oil, Hydrolyzed Pearl, Pearl Powder, Oxygen, Perfume

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indication & Usage: Use at the last stage of basic skin care. Dispense an appropriate amount of the product and gently apply along the skin texture. Lightly pat for absorption.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GEM MIRACLE BLACK PEARL O2 WHITENING 
niacinamide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-330
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (NIACINAMIDE) Niacinamide1.20 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:70341-330-0160 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2015
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIOperations
The Saem International Co., Ltd.689402402manufacture(70341-330)

 
The Saem International Co., Ltd.

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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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