GLIZIGEN SKIN PROTECTANT- glycerin spray 
Catalysis, SL

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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Glycerin 0.5%................Skin Protectant

Bottle

Propyleneglycol, water, Polysorbate 80, Glycyrrhizinic Acid, Sodium Benzoate, Potassium Sorbate, TEA

box

GLIZIGEN SKIN PROTECTANT 
glycerin spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.8 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.1 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 100 mg  in 1 mL
PROPANEDIOL (UNII: 5965N8W85T) 50 mg  in 1 mL
TEA LEAF (UNII: GH42T47V24) 0.1 mg  in 1 mL
GLYCYRRHIZIN (UNII: 6FO62043WK) 0.1 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64539-004-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/07/2017
Labeler - Catalysis, SL (862795119)
Registrant - Catalysis, SL (862795119)
Establishment
NameAddressID/FEIBusiness Operations
Catalysis, SL862795119manufacture(64539-004)

Revised: 6/2017
Document Id: 530af5d6-debd-487a-e054-00144ff8d46c
Set id: 4ef6dae3-dbf2-25bc-e054-00144ff88e88
Version: 2
Effective Time: 20170628
 
Catalysis, SL