LIDOCAINE AND PRILOCAINE CREAM- lidocaine and prilocaine cream cream
TriRx Huntsville Pharmaceutical Services
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Rhodes Pharmaceuticals Lidocaine and Prilocaine Cream
Description
![Description](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Description.jpg)
Clinical Pharmacology
![Clinical Pharmacology](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Clinical+Pharmacology+Mechanism+of+Action.jpg)
Pharmacokinetics 1
![Pharmacokinetics 1](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Pharmacokinetics_1.jpg)
Pharmacokinetics 2
![Pharmacokinetics 2](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Pharmacokinetics_2.jpg)
Clinical Studies
![Clinical Studies](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Clinical+Studies.jpg)
Individualization of Dose 1
![Individualization of Dose 1](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Individualization+of+Dose_1.jpg)
Individualization of Dose 2
![Individualization of Dose 2](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Individualization+of+Dose_2.jpg)
Indications and Usage
![Indications and Usage](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Indications+and+Usage.jpg)
Contraindications
![Contraindications](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Contraindications.jpg)
Warnings
![Warnings](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Warnings.jpg)
Precautions
![Precautions](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Precautions.jpg)
Information for Patients
![Information for Patients](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Information+for+Patients.jpg)
Drug Interactions
![Drug Interactions](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Drug+Interactions.jpg)
Use in Pregnancy
![Use in Pregnancy](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Use+in+Pregnancy.jpg)
Labor and Delivery
![Labor and Delivery](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Labor+and+Delivery.jpg)
Nursing Mothers
![Nursing Mothers](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Nursing+Mothers.jpg)
Pediatric Use 1
![Pediatric Use 1](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Pediatric+Use+1.jpg)
Pediatric Use 2
![Pediatric Use 2](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Pediatric+Use+2.jpg)
Geriatric Use
![Geriatric Use](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Geriatric+Use.jpg)
Adverse Reactions
![Adverse Reactions](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Adverse+Reactions.jpg)
Overdosage
![Overdosage](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Overdosage.jpg)
Dosage and Administration
![Dosage and Administration](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Dosage+and+Administration.jpg)
Pediatric Patients-Intact Skin
![Pediatric Patients Intact Skin](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Pediatric+Patients-Intact+Skin.jpg)
Instructions for Application
![Instructions for Application](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Instructions+for+Application.jpg)
How Supplied
![How Supplied](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/How+Supplied.jpg)
Tube 5g
![Tube 5g](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Tube+5g.jpg)
Tube 30g
![Tube 30g](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Tube+30g.jpg)
Carton 5g
![Carton 5g](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Carton+5g.jpg)
Carton 30g
![Carton 30g](https://fda.report/DailyMed/19fb6823-fcd8-7c08-e063-6294a90aa62e/Carton+30g.jpg)
LIDOCAINE AND PRILOCAINE CREAM
lidocaine and prilocaine cream cream |
Product Information |
Product Type | HUMAN PRESCRIPTION DRUG | Item Code (Source) | NDC: 80432-053 |
Route of Administration | TOPICAL |
|
Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) | LIDOCAINE | 25 mg in 1000 mg |
PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) | PRILOCAINE | 25 mg in 1000 mg |
|
Inactive Ingredients |
Ingredient Name | Strength |
SODIUM HYDROXIDE (UNII: 55X04QC32I) | |
PEG-54 HYDROGENATED CASTOR OIL (UNII: 0WZF1506N9) | |
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) | |
WATER (UNII: 059QF0KO0R) | |
|
|
Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 80432-053-65 | 5000 mg in 1 TUBE; Type 0: Not a Combination Product | 08/14/2023 | |
2 | NDC: 80432-053-71 | 30000 mg in 1 TUBE; Type 0: Not a Combination Product | 08/14/2023 | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA213253 | 08/14/2023 | |
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Labeler - TriRx Huntsville Pharmaceutical Services
(117090286)
|