BIOTOC REGEN- glycerin cream 
Dermafirm INC.

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, Galactomyces Ferment Filtrate, Copper Tripeptide-1, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4, Niacinamide, Adenosine, etc.

Skin protectant - Intensive nutrition cream, Improving wrinkle, Superior Moisturizing

keep out of reach of the children

At the end of the basic care, apply to the entire face and neck and let it absorb by tapping lightly.

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


1

BIOTOC REGEN 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71638-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10.03 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ADENOSINE (UNII: K72T3FS567)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71638-0011-150 g in 1 JAR; Type 0: Not a Combination Product03/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34703/01/2018
Labeler - Dermafirm INC. (690171603)
Registrant - Dermafirm INC. (690171603)
Establishment
NameAddressID/FEIBusiness Operations
Dermafirm INC.690171603label(71638-0011) , pack(71638-0011) , manufacture(71638-0011)

Revised: 4/2018
Document Id: 699f2e62-0569-3d4e-e053-2991aa0a7d93
Set id: 699f2e62-0568-3d4e-e053-2991aa0a7d93
Version: 1
Effective Time: 20180411
 
Dermafirm INC.