FEDORA CONCENTRATING HYDRO SERUM - glycerin liquid 
Fedora International Co., Ltd.

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.

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Drug Facts

glycerin


water, niacinamide, etc.


anti wrinklewhiteningskin protectant


keep out of reach of the children


apply proper amount to the skin

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


package label
FEDORA CONCENTRATING HYDRO SERUM 
glycerin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62620-5001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.01 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62620-5001-135 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/26/2015
Labeler - Fedora International Co., Ltd. (689049099)
Registrant - Fedora International Co., Ltd. (689049099)
Establishment
NameAddressID/FEIBusiness Operations
Fedora International Co., Ltd.689049099manufacture(62620-5001)

Revised: 10/2015
Document Id: 6b24fd30-bd26-4dff-bca8-4abd8e7057d3
Set id: 0b8b0b30-4983-4278-b8bb-1588249f7d28
Version: 1
Effective Time: 20151026
 
Fedora International Co., Ltd.