Rhodes Pharmaceuticals Lidocaine and Prilocaine Cream

Lidocaine and Prilocaine Cream by

Drug Labeling and Warnings

Lidocaine and Prilocaine Cream by is a Prescription medication manufactured, distributed, or labeled by TriRx Huntsville Pharmaceutical Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIDOCAINE AND PRILOCAINE CREAM- lidocaine and prilocaine cream cream 
TriRx Huntsville Pharmaceutical Services

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Rhodes Pharmaceuticals Lidocaine and Prilocaine Cream

Description

Clinical Pharmacology

Pharmacokinetics 1

Pharmacokinetics 2

Clinical Studies

Individualization of Dose 1

Individualization of Dose 2

Indications and Usage

Contraindications

Warnings

Precautions

Information for Patients

Drug Interactions

Use in Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use 1

Pediatric Use 2

Geriatric Use

Adverse Reactions

Overdosage

Dosage and Administration

Pediatric Patients-Intact Skin

Instructions for Application

How Supplied

Tube 5g

Tube 30g

Carton 5g

Carton 30g

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213253	08/14/2023

Labeler - TriRx Huntsville Pharmaceutical Services (117090286)

Revised: 6/2024

Document Id: 1a013e76-e5e3-56b2-e063-6394a90a5f22

34391-3

Set id: 19fb6823-fcd8-7c08-e063-6294a90aa62e

Version: 2

Effective Time: 20240603