FDA.reportPublic FDA data

PUREGEN LABS Maximum Strength Lidocaine 5% Cream

Manufacturer
Advanced Rx LLC
Effective date
2024-04-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:19

Label at a glance#

ProductPUREGEN LABS Maximum Strength Lidocaine
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

Helps relieve the local itching and discomfort in the perianal area  For the temporary relief of pain, irritation” or burning.

Dosage and administration

Adults: When practical, cleanse the affected area “with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad  Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.  Children under 12 years of age: consult a doctor.  Apply externally to the affected area up to 6 times daily or after each bowel movement.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5.00 %

Purpose

OTC - PURPOSE SECTION

Anorectal (hemorrhoidal)

Uses

INDICATIONS & USAGE SECTION

  • Helps relieve the local itching and discomfort in the perianal area 
  • For the temporary relief of pain, irritation” or burning.

Warnings:

WARNINGS SECTION

For external use only

Do not

OTC - DO NOT USE SECTION

  • exceed the recommended daily dosage unless directed by a doctor. 
  • put this product into the rectum by using fingers or any mechanical device or applicator.

When using this product

OTC - WHEN USING SECTION

  • If the condition worsens or does not improve within 7 days, consult a doctor. 
  • In case of bleeding, consult a doctor promptly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Allergy alert 

  • Certain persons can develop allergic reactions to ingredients in this product.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults:

  • When practical, cleanse the affected area “with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad 
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 
  • Children under 12 years of age: consult a doctor. 
  • Apply externally to the affected area up to 6 times daily or after each bowel movement.

Other information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Ethylhexylglycerin, Ethylhexyl Stearate, Hydrogenated Polyisobutene, Lecithin, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trideceth-6

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-630-8895

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN1
1366789lidocaine 50 MG/ML Rectal CreamSCD1
1366789lidocaine 5 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-813-06PUREGEN LABS Maximum Strength Lidocaine170 g in 1 TUBECREAM1701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-813PUREGEN LABS MAXIMUM STRENGTH LIDOCAINE (LIDOCAINE) CREAM [ADVANCED RX LLC]1Current NDC, 1 package rows20240423_f4f89582-49e6-424a-bea7-0694484a7c99.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80513-81380513-813-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECETH-63T5PCR2H0CIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUREGEN LABS Maximum Strength LidocaineLIDOCAINEAdvanced Rx LLCf4f89582-49e6-424a-bea7-0694484a7c992024-04-11WarningsExact identifier
ndc (package): 80513-813-06
ndc (product): 80513-813
ndc11 (package): 80513081306
spl id: 15cfdc73-c2f3-528e-e063-6394a90a07ae
spl set id: f4f89582-49e6-424a-bea7-0694484a7c99

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.