GLYZIGEN SINGLE DOSE INTIMATE GEL- glycerin gel 
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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Glyzigen single dose Intimate Gel

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

+ 34 913456902 Monday to Friday: 9:00 am to 5:00 pm

Water, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Lactic Acid, Diazolidinyl Urea, Glycyrrhizinic,Acid, Sodium Benzoate, Potassium Sorbate, Phytosphingosine HCl, Parfum

Glyzigen Single Dose

Single use

GLYZIGEN SINGLE DOSE INTIMATE GEL 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-007
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
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 12 mg  in 1 mL
GLYCYRRHIZIN (UNII: 6FO62043WK) 0.1 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 mg  in 1 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 20 mg  in 1 mL
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) 3 mg  in 1 mL
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) 0.01 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT) 0.36 mg  in 1 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 0.3 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.1 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 100 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64539-007-021 in 1 PACKAGE01/11/2018
1NDC:64539-007-015 mL in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/11/2018
Labeler - Catalysis, SL (862795119)
Registrant - Catalysis, SL (862795119)
Establishment
NameAddressID/FEIBusiness Operations
Catalysis, SL862795119manufacture(64539-007)

Revised: 1/2018
Document Id: 628d633c-6f69-e9d1-e053-2991aa0a2986
Set id: 628d633c-6f68-e9d1-e053-2991aa0a2986
Version: 1
Effective Time: 20180111
 
Catalysis, SL