Lidonumb - Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd

Manufacturer
Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd
Effective date
2026-09-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-22 03:01:14

Label at a glance#

ProductLidonumb
Active ingredientLIDOCAINE
Label structure12 sections

Indications and uses

Temporarily relieves the pain and itching due to anorectal disorders.

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 soft cloth before application of this product. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the pain and itching due to anorectal disorders.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not use in large quantities, particularly over large surfaces or blistered areas
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechnical device or applicator.

Stop use and ask a doctor if

SPL UNCLASSIFIED 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 a 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

  • 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 soft cloth before application of this product.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, carbomer 940, hydrolysed soy lecithin, isopropyl myristate, polysorbate 80, propylene glycol, triethanolamine, vitamin E acetate, water

Questions or comments?

SPL UNCLASSIFIED SECTION

Call 1-844-474-7464

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. lic. No.: G/25/1362

Issued: 05/2026

lidonumb-15g-cartonlidonumb-15g-carton

lidonumb-30g-cartonlidonumb-30g-carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357237353301GTIN-13: 0357237353301
EAN-13: 0357237353301
GTIN-12: 357237353301
UPC-A: 357237353301
GTIN storage (14 digits): 00357237353301
lidonumb-30g-carton.jpg

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
57237-35357237-353-15, 57237-353-30

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-16full-release2026-06-01 01:26:39

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
4a93eba8-3530-42da-ae73-b7d82cba005ee7569ceb-6e4d-4417-9e61-ab86fc7e05c62025-12-16WarningsExact identifier
spl set id: e7569ceb-6e4d-4417-9e61-ab86fc7e05c6

Reported adverse events (FAERS/openFDA)#

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