Label: EBSL-5- lidocaine hydrochloride kit
- NDC Code(s): 59898-140-40, 59898-200-10, 59898-200-35, 59898-200-49
- Packager: Water-Jel Technologies
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated December 7, 2017
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INGREDIENTS AND APPEARANCE
EBSL-5
lidocaine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59898-140 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59898-140-40 1 in 1 KIT; Type 0: Not a Combination Product 06/11/2014 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 10 PACKET 35 mL Part 2 1 BOTTLE, PLASTIC 59 mL Part 1 of 2 BURN JEL
lidocaine hydrochloride gelProduct Information Item Code (Source) NDC:59898-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) TEA TREE OIL (UNII: VIF565UC2G) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) TROLAMINE (UNII: 9O3K93S3TK) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59898-200-49 10 in 1 BOX 1 NDC:59898-200-35 3.5 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/11/2014 Part 2 of 2 BURN JEL
lidocaine hydrochloride gelProduct Information Item Code (Source) NDC:59898-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) TEA TREE OIL (UNII: VIF565UC2G) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) TROLAMINE (UNII: 9O3K93S3TK) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59898-200-10 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/11/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/11/2014 Labeler - Water-Jel Technologies (155522589) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(59898-140)