GLIZIGEN 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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Glizigen single dose Intimate Gel

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

Vial

  • Stop use and ask a doctor if rash occurs
  • Children under 6 months: ask a doctor

  • Keep out of reach of children

  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep our of the eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.
  • Keep out of reach of children
  • Children under 6 months: as a doctor.

  • Apply a small amount the intimate parts and gently wash. Rinse with water
  • Maybe used as often as necessary

  • Apply a small amount the intimate parts and gently wash. Rinse with water
  • Maybe used as often as necessary

  • Stop use and ask a doctor if rash occurs
  • Children under 6 months: ask a doctor

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

  • keep the product in a cool and dry place

  • Apply a small amount the intimate parts and gently wash. Rinse with water
  • Maybe used as often as necessary

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

Glizigen Single Dose

Caja

GLIZIGEN SINGLE DOSE INTIMATE GEL 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-016
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:64539-016-021 in 1 PACKAGE03/17/2018
1NDC:64539-016-015 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 finalpart34703/17/201801/01/2019
Labeler - Catalysis, SL (862795119)
Registrant - Catalysis, SL (862795119)
Establishment
NameAddressID/FEIBusiness Operations
Catalysis, SL862795119manufacture(64539-016)

Revised: 6/2019
Document Id: 8a539ab8-b456-05c1-e053-2a95a90ac33c
Set id: 67a32901-bd33-5d8b-e053-2991aa0ab943
Version: 2
Effective Time: 20190602
 
Catalysis, SL