Label: LIDOCAINE AND PRILOCAINE cream
- NDC Code(s): 70771-1872-2, 70771-1872-5, 70771-1872-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 30, 2024
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INGREDIENTS AND APPEARANCE
LIDOCAINE AND PRILOCAINE
lidocaine and prilocaine creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1872 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 25 mg in 1 g PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) PRILOCAINE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1872-8 5 in 1 CARTON 01/01/2025 1 NDC:70771-1872-5 5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70771-1872-2 1 in 1 CARTON 01/01/2025 2 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA219120 01/01/2025 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (650199482) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1872) , MANUFACTURE(70771-1872)