GLIZIGEN GEL INTIMATE- 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.

----------

Glizigen Intimate Gel

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

Bottle

+ 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

Box

GLIZIGEN GEL INTIMATE 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-017
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
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
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) 0.01 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 100 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64539-017-021 in 1 BOTTLE03/18/2018
1NDC:64539-017-01250 mL in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/18/2018
Labeler - Catalysis, SL (862795119)
Registrant - Catalysis, SL (862795119)
Establishment
NameAddressID/FEIBusiness Operations
Catalysis, SL862795119manufacture(64539-017)

Revised: 3/2018
Document Id: 67bbbe49-de55-c9dd-e053-2a91aa0ae8a4
Set id: 67bbbae5-7c02-c23e-e053-2a91aa0a00b7
Version: 1
Effective Time: 20180318
 
Catalysis, SL