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
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Drug Label Information
Updated January 11, 2018
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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)