FDA.reportPublic FDA data

ElixirLidoFast Lidocaine 5% Cream

Manufacturer
ELIXIR HEALTHCARE USA, LLC.
Effective date
2025-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:22:49

Label at a glance#

ProductElixirLidoFast
Active ingredientLIDOCAINE
Label structure15 sections

Indications and uses

Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorder.

Dosage and administration

apply liberally as often as necessary For diaper rash: • change wet or soiled diapers promptly • cleanse the diaper area and allow to dry • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Anorectal (hemorrhoidal) cream

Uses

INDICATIONS & USAGE SECTION

Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorder.

Warnings:

WARNINGS SECTION

• For external use only

When using this product,

OTC - WHEN USING SECTION

• Avoid contact with eyes.
• Do not exceed recommended dosage unless direct by a doctor.
• Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Dosage

DOSAGE & ADMINISTRATION SECTION

• If pregnant or breastfeeding: ask a health professional before use.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• rectal bleeding occurs
• Condition worsens or does not improve within 7 days
• Allergic reaction occurs to ingredients in this product.
• Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
• Symptoms clear up and return within few days.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally as often as necessary
For diaper rash:
• change wet or soiled diapers promptly
• cleanse the diaper area and allow to dry
• apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Trolamine, Vitamin E Acetate, Purified Water

Other information

SPL UNCLASSIFIED SECTION

• Store at temperature below 30°C.
• Do not freeze. Protect from direct sunlight.

Packaging label for the tube 30g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elixir

LINDOCAINE CREAM 5%

Topical Cream

WORK FASTER LASTS LONGER

image descriptionimage description

Packaging label for the tube 60g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elixir

LINDOCAINE CREAM 5%

Topical Anorectal Cream

WORK FASTER LASTS LONGER

Pian Relife For Hemorrhoids & other 

Anorectal Disorders

Relieves Pian, Relieves Itching, Relieves Burining

1 Tube Net WT.2 oz (60g)

image descriptionimage description

Packaging label for the Jar 142g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elixir

STONGEST 

NON-PRESCIPTION

LINDOCIANE

ANORECTAL (HEMORRHOIDAL) CREAM

5% LINDOCAINE, WORKS FASTER LASTS LONGER 5oz VALUE SIZE!

Child Resistant Packaging

5oz| 142g

image descriptionimage description

Packaging label for the Jar 156g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elizir LdioEase Numbing Cream

Lindocaine Anorectal Cream 5% w/w

5% LIDOCAINE 

WORK FASTER LASTS LONGER

5.5oz|156g

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1534792lidocaine 5 % Topical CreamPSN1
1534792lidocaine 50 MG/ML Topical CreamSCD1
1534792lidocaine 5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84546-0010-1ElixirLidoFast30 g in 1 TUBECREAM301
84546-0010-1ElixirLidoFast1 in 1 CARTONCREAM11
84546-0010-2ElixirLidoFast1 in 1 CARTONCREAM11
84546-0010-2ElixirLidoFast60 g in 1 TUBECREAM601
84546-0010-3ElixirLidoFast142 g in 1 JARCREAM1421
84546-0010-4ElixirLidoFast156 g in 1 JARCREAM1561

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84546-001084546-0010-1, 84546-0010-2, 84546-0010-3, 84546-0010-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER 9404Q93RCW27EIACT
CHOLESTEROL97C5T2UQ7JIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
ElixirLidoFastLIDOCAINE 5% CREAMELIXIR HEALTHCARE USA, LLC.45de5a3d-06c2-aa02-e063-6294a90a63d32025-12-13WarningsExact identifier
ndc (package): 84546-0010-4
ndc (package): 84546-0010-2
ndc (package): 84546-0010-3
ndc (package): 84546-0010-1
ndc (product): 84546-0010
ndc11 (package): 84546001002
ndc11 (package): 84546001001
ndc11 (package): 84546001003
ndc11 (package): 84546001004
spl id: 45de57d8-ec5f-bf9e-e063-6294a90a37d2
spl set id: 45de5a3d-06c2-aa02-e063-6294a90a63d3

Reported adverse events (FAERS/openFDA)#

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