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BRIGHT EYE VITALIZER by AMI Cosmetic Co.,Ltd.

Medically reviewed on December 6, 2017

Dosage form: cream
Ingredients: DIMETHICONE 1g in 100mL
Labeler: AMI Cosmetic Co.,Ltd.
NDC Code: 59535-0269

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.

Drug Facts

dimethicone

Water, Glycerin, Butylene Glycol, Etc

Skin Protectant - Anti Wrinkle, brightening

keep out of reach of the children

apply proper amount to the eye area

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children

for external use only

BRIGHT EYE VITALIZER 
dimthicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59535-0269
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:59535-0269-116 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/07/2017
Labeler - AMI Cosmetic Co.,Ltd. (631055345)
Registrant - AMI Cosmetic Co.,Ltd. (631055345)
Establishment
NameAddressID/FEIOperations
AMI Cosmetic Co.,Ltd.631055345label(59535-0269)
Establishment
NameAddressID/FEIOperations
Nowcos.Co.,Ltd689914984manufacture(59535-0269)

 
AMI Cosmetic 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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