XR CELLULAR MAGIC- sodium hyaluronate gel 
MESO SYSTEM S.A.

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.

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XR CELLULAR MAGIC

Warnings

Stop use and ask a Doctor if skin rash occurs

WARNINGS

USES

DIRECTIONS

QUESTIONS OR COMMENTS ?

ACTIVE INGREDIENTS

Active Ingredients Purpose

Sodium Hyaluronate 0.1%....................................Skin Protectant

Inactive Ingredients

Water, Propylene Glycol, Methylsilanol Mannuronate, Glyceryl Linoleate, Glyceryl Linolenate, Glyceryl Arachidonate, Phenoxyethanol, Peg-35 Castor Oil, Borago Officinalis Extract, Ascorbyl Palmitate, Dimethyl Mea, Ethylhexylglycerin

Product

Apply a small amount in the face and neck, morning and evening

XR CELLULAR MAGIC

SKIN PROTECTANT

Box

XR CELLULAR MAGIC 
sodium hyaluronate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70663-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) 0.2 mg  in 1 mL
BORAGO OFFICINALIS FLOWER (UNII: 7X23S1OW1N) 0.2 mg  in 1 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.1 mg  in 1 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40) 10 mg  in 1 mL
SODIUM MANNURONATE METHYLSILANOL (UNII: 6ZK10JO456) 5 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 80.3 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
PEG-30 GLYCERYL LINOLEATE (UNII: UPJ8VI2ZOC) 1 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
GLYCERYL ARACHIDONATE (UNII: I4WS2B978B) 1 mg  in 1 mL
GLYCERYL LINOLENATE (UNII: SGB6X4G86K) 1 mg  in 1 mL
DEANOL (UNII: 2N6K9DRA24) 0.1 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70663-008-021 in 1 BOX12/17/2016
1NDC:70663-008-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/17/2016
Labeler - MESO SYSTEM S.A. (768263100)
Registrant - MESO SYSTEM S.A. (768263100)
Establishment
NameAddressID/FEIBusiness Operations
MESO SYSTEM S.A.768263100manufacture(70663-008)

Revised: 12/2016
Document Id: 43e51c3c-add3-3f98-e054-00144ff88e88
Set id: 43e51c3c-add2-3f98-e054-00144ff88e88
Version: 1
Effective Time: 20161217
 
MESO SYSTEM S.A.