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

Clinical Pharmacology

Clinical Pharmacology

Pharmacokinetics 1

Pharmacokinetics 1

Pharmacokinetics 2

Pharmacokinetics 2

Clinical Studies

Clinical Studies

Individualization of Dose 1

Individualization of Dose 1

Individualization of Dose 2

Individualization of Dose 2

Indications and Usage

Indications and Usage

Contraindications

Contraindications

Warnings

Warnings

Precautions

Precautions

Information for Patients

Information for Patients

Drug Interactions

Drug Interactions

Use in Pregnancy

Use in Pregnancy

Labor and Delivery

Labor and Delivery

Nursing Mothers

Nursing Mothers

Pediatric Use 1

Pediatric Use 1

Pediatric Use 2

Pediatric Use 2

Geriatric Use

Geriatric Use

Adverse Reactions

Adverse Reactions

Overdosage

Overdosage

Dosage and Administration

Dosage and Administration

Pediatric Patients-Intact Skin

Pediatric Patients Intact Skin

Instructions for Application

Instructions for Application

How Supplied

How Supplied

Carcinogenesis

Tube 5g

Tube 5g

Tube 30g

Tube 30g

Carton 5g

Carton 5g

Carton 30g

Carton 30g

LIDOCAINE AND PRILOCAINE CREAM 
lidocaine and prilocaine cream cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80432-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE25 mg  in 1000 mg
PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) PRILOCAINE25 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80432-053-655000 mg in 1 TUBE; Type 0: Not a Combination Product08/14/2023
2NDC:80432-053-7130000 mg in 1 TUBE; Type 0: Not a Combination Product08/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21325308/14/2023
Labeler - TriRx Huntsville Pharmaceutical Services (117090286)

Revised: 6/2024
Document Id: 1a013e76-e5e3-56b2-e063-6394a90a5f22
Set id: 19fb6823-fcd8-7c08-e063-6294a90aa62e
Version: 2
Effective Time: 20240603
 
TriRx Huntsville Pharmaceutical Services