1. Derma Veil is a lyophilized low viscosity, non-toxic, bioabsorbable and biodegradable tissue reconstructive material used in the reinforcement of skin and other soft tissue, typically by serving as a space-occupying supplement for the intercellular matrix of connective tissue.

2. Derma Veil is an injectable single use medical device incorporated as a hydrophilic matrix. The active principle is composed of glycolic acid (hydroxyacetic) bound to the polymeric column of polylactic acid [PURASORB® Poly (L-lactide)] which is homogeneously dispersed throughout and its rate of release is controlled by diffusion, which prolongs its sustained repairing action through the slow dissolution of the compoud.

3. Derma Veil ® is immunologically inactive, biocompatible and absorbable and is degraded by hydrolysis. The degradation begins firts by water diffusion in the material, initially at the more amorphous zones, followed by hydrolysis, material fragmentation and finally, a more extensive hydrolysis along with phagocytosis, diffusion and metabolization. Elimination occurs primarily through the respiratory tract.

4. Each box of Derma Veil contains 2 vials and an Instruction for Use leaflet.

5. Each vial of Derma Veil is made of transparent borosilicate glass, sealed with a siliconized halobutyl stopper secured by an aluminum ring with a "flip off" plastic cap. The vial has 10 mL capacity and contains 236,14 mg. of a lyophilized, Sterile, pyrogen free, crystalline white powder asymmetric micro-particles (40 to 60 mµ) made of:

             a.  POLYLACTIC ACID  a biocompatible, biodegradable synthetic polymer for medical applications,                                                 [PURASORB^® Poly (L-lactide)] Also known as (synonyms): Poly-L-lactide,                                                  Polylactide PL, PLLA, PLA.

             b.  GLICOLIC ACID       a biocompatible, biodegradable, high purity hidroxyacetic acid monomer                                                     for medical applications.

                c.  EXCIPIENTS

                     Qualitative and quantitative composition:

                  Polylactic: (150,000 mg.) + Glycolic: (0,035 mg) + Excipients: (86,110 mg.) = 236,145 mg.

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  Polylactic acid: Also known as (synonyms*): Poly (L-lactide), Polylactide, PL, PLLA, PL, PLA. The polylactid acid used in Derma Veil formula is [PURASORB® Poly (L-lactide)] a synthesis polymer for medical applications manufactured in The Netherlands by PURAC biochem bv.

* US government webside for polylactic synonyms:  http://chem.sis.nlm.nih.gov/chemidplus/rn/26811-96-1

6. Derma Veil  may be stored at temperatures between 15º C and 30º C.
7. Derma Veil does not require refrigeration.           

               Download file: "Instructions for Use"