FDA.reportPublic FDA data

RECTALIEF LIDOCAINE 5 CREAM

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2025-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:13

Label at a glance#

ProductRETALIEF LIDOCAINE 5
Active ingredientLIDOCAINE
Label structure12 sections

Dosage and administration

when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying Adults and children 12 years of age and older: apply externally to the affected area not more than 6 times a day. children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% W/W

OTC - PURPOSE SECTION

Local Anesthetic Anorectal (Hemorrhoidal) Cream

INDICATIONS & USAGE SECTION

helps relieve the pain, itching, and burning, associated with hemorrhoids and anorectal disorders

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes
  • do not use more than directed unless directed by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction occurs
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • Adults and children 12 years of age and older: apply externally to the affected area not more than 6 times a day.
  • children under 12 years of age: consult a doctor.

OTHER SAFETY INFORMATION

Store between 20°-25° C (68°-77° F)

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton rectaliefCarton rectaliefNDC 69618-075-78

Reliable 1 Laboratories

Rectalief

Anorectal Cream

Lidocaine 5%

Relieves Pain, Itching & Burning

Highest Strength of Non-Rx Lidocaine Available

1OZ (30gm)

QUESTIONS

1-516-341-0666 Monday- Friday

Distributed by

Reliable 1 Labs

99 W. Hawthorne Ave #610

Valley Stream, NY 11580

www.reliable1labs.com TubeTube

Made in China

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 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
69618-075-78RETALIEF LIDOCAINE 530 g in 1 TUBECREAM301
69618-075-78RETALIEF LIDOCAINE 51 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-075RETALIEF LIDOCAINE 5 (LIDOCAINE) CREAM [RELIABLE 1 LABORATORIES LLC]1Current NDC, 2 package rows20250121_2c262f3c-8cb2-4384-e063-6294a90a436d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-075-78GM - Gram69618-0756604d2cb-64ea-441e-812f-45d66edaf46412025-02-10

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-07569618-075-78

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
LIDOCAINE98PI200987ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
ALOE BARBADENSIS LEAF JUICEZY81Z83H0XIACT
CHOLESTEROL97C5T2UQ7JIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
CARBOMER0A5MM307FCIACT

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
RETALIEF LIDOCAINE 5LIDOCAINEReliable 1 Laboratories LLC2c262f3c-8cb2-4384-e063-6294a90a436d2025-01-20WarningsExact identifier
ndc (package): 69618-075-78
ndc (product): 69618-075
ndc11 (package): 69618007578
spl id: 2c262f3c-8cb3-4384-e063-6294a90a436d
spl set id: 2c262f3c-8cb2-4384-e063-6294a90a436d

Reported adverse events (FAERS/openFDA)#

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