Xyralid - lidocaine 5% cream

Manufacturer
Innovus Pharmaceuticals, Inc.
Effective date
2017-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:14:51

Label at a glance#

ProductXyralid
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

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

Dosage and administration

When practical, clean area with mild soap and warm water and rinse thoroughly, Gently dry by patting or blotting wiht toilet tissue or soft cloth before applying. Adults and children 12 years and older: Apply externally to the affected are up to six times a day Children under 12 years of age: Consult a doctor

Storage and handling

Store at 20-25 o C (66-77 o F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Local anesthetic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any other mechanical device or applicator

Stop and ask a doctor if

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 day
  • allergic reaction occurs to ingredients in this product
  • symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symtpoms 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, clean area with mild soap and warm water and rinse thoroughly, Gently dry by patting or blotting wiht toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: Apply externally to the affected are up to six times a day
  • Children under 12 years of age: Consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 20-25oC (66-77oF) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, glyceryl stearate, glyceryl stearate SE, methylparaben, PEG-100 stearate, pertrolatum, propylene glycol, propylparaben, water, white beeswax

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57483-108-052023-01-13C16284748780-19d75b9d0-0847-f424-e053-dadaa90a57ceXyralid - lidocaine 5% cream
57483-108-052020-01-31C16284748780-19d75b9d0-0847-f424-e053-dadaa90a57ceXyralid - lidocaine 5% cream

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
57483-10857483-108-05

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
fa4a5b64-27ae-4663-89c9-eacccc9377d0158c7036-1a48-48c4-960c-cf99a7aa9cb12023-01-13WarningsExact identifier
spl set id: 158c7036-1a48-48c4-960c-cf99a7aa9cb1

Reported adverse events (FAERS/openFDA)#

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