Label: GLYZIGEN SINGLE DOSE INTIMATE GEL- glycerin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 64539-007-01, 64539-007-02 - Packager: Catalysis, SL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 11, 2018
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
GLYZIGEN SINGLE DOSE INTIMATE GEL
glycerin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64539-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:64539-007-02 1 in 1 PACKAGE 01/11/2018 1 NDC:64539-007-01 5 mL in 1 DOSE PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/11/2018 Labeler - Catalysis, SL (862795119) Registrant - Catalysis, SL (862795119) Establishment Name Address ID/FEI Business Operations Catalysis, SL 862795119 manufacture(64539-007)
