Lidocaine Roll-on PS

Manufacturer
YYBA Corp
Effective date
2026-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:59:09

Label at a glance#

ProductLidocaine Roll-on
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

Helps relieve local itching and discomfort in the perianal area For the temporary relief of pain, irritation or burning Temporarily shrinks hemorrhoidal tissue

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. Apply externally to the affected area up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor.

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts - Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Anorectal (hemorrhoidal)

Uses

INDICATIONS & USAGE SECTION

  • Helps relieve local itching and discomfort in the perianal area
  • For the temporary relief of pain, irritation or burning
  • Temporarily shrinks hemorrhoidal tissue

Warnings

WARNINGS SECTION

For external use only

  • Do not exceed the recommended daily dosage unless directed by a doctor. Do not put this product into the rectum by using your fingers or any mechanical device or applicator.
  • Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
  • When using this product 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 the symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
  • Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
  • Allergy alert: Certain persons can develop allergic reactions to ingredients in this product.

Pregnancy or Breast-Feeding Warning

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep Out of Reach of Children

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

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. Apply externally to the affected area up to 6 times daily or after each bowel movement.

Children under 12 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polysorbate 60, Sodium Hydroxide, Water (Aqua).

Questions?

OTC - QUESTIONS SECTION

Call 1-866-933-6337

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

rollonrollon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1652104lidocaine 5 % Rectal GelPSN1
1652104lidocaine 0.05 MG/MG Rectal GelSCD1
1652104lidocaine 5 % Rectal GelSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73581-023-74Lidocaine Roll-on74 mL in 1 BOTTLE, WITH APPLICATORGEL741

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
73581-02373581-023-74

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
Lidocaine Roll-onLIDOCAINEYYBA Corp52d060df-2095-dd68-e063-6394a90a77402026-05-27WarningsExact identifier
ndc (package): 73581-023-74
ndc (product): 73581-023
ndc11 (package): 73581002374
spl id: 52d060df-2096-dd68-e063-6394a90a7740
spl set id: 52d060df-2095-dd68-e063-6394a90a7740

Reported adverse events (FAERS/openFDA)#

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