QCDMO Lidocaine 5%

Manufacturer
YYBA CORP
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-08 02:01:52

Label at a glance#

ProductLidocaine Hydrochloride
Active ingredientLIDOCAINE
Label structure11 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 applying. 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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Anorectal (hemorrhoidal) 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

  • avoid contact with etes
  • do not use in large quantities, particulary 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 mechanical device or applicator

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 inscrease
  • 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 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 applying.
  • 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

STORAGE AND HANDLING 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

aloe barbadensis leaf extract, cetyl alcohol,citric acid, glycerin, glyceryl strearate SE,mineral oil, PEG-100 stearate,phenoxy-ethanol,purified water, stearyl alcohol,vitamin E, white petrolatum, xanthan gum.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-866-933-6337

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130373581000296GTIN-13: 0373581000296
EAN-13: 0373581000296
GTIN-12: 373581000296
UPC-A: 373581000296
GTIN storage (14 digits): 00373581000296
Screenshot 2026-08-04 134915.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73581-12073581-120-01, 73581-120-02, 73581-120-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsExact identifier
ndc (package): 73581-120-06
ndc (package): 73581-120-02
ndc (package): 73581-120-01
ndc (product): 73581-120
ndc11 (package): 73581012002
ndc11 (package): 73581012006
ndc11 (package): 73581012001
spl id: 582a0001-da1f-909a-e063-6394a90a2b11
spl set id: 582a0001-da1e-909a-e063-6394a90a2b11

Reported adverse events (FAERS/openFDA)#

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