FDA.reportPublic FDA data

ACTIVE INGREDIENT

Manufacturer
OL PHARMA TECH LLC. (Drs. Pharmacy) | OL PHARMA TECH LLC. | OL PHARMA TECH
Effective date
2026-07-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-17 21:45:45

Label at a glance#

ProductLidocaine cream
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

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

Dosage and administration

Adult and children 12 years and over: 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 application of this product. 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%

PURPOSE

OTC - PURPOSE SECTION

Topical anesthetic

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

  • use only as directed.
  • Avoid contact with eyes.
  • do not exceed recommended dosage unless directed by a doctor.
  • do not out this product into the rectum by using fingers or any mechanical device or applicator.

STOP USING AND ASK A DOCTOR IF:

OTC - STOP USE SECTION

  • rectal bleeding occurs.
  • condition worsens or does not improve within 7 days.
  • symptoms clear up and occur again within a few days.
  • an allergic reaction develops to ingredients in this product.
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
  • 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 and pets.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • Adult and children 12 years and over:

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 application of this product. apply externally to the affected area up to 6 times a day

  • children under 12 years of age: consult a doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store between 15°-30° C (59°-30° F).

OTC - QUESTIONS SECTION

TELEPHONE NUMBER : 248 325 4231

INACTIVE INGREDIENT SECTION

water. stearic acid, vitamin E, EDTA, cetostearyl alcohol, sodium cetostearyl sulfate, trolamine, methylparaben, mineral oil, propylene glycol, propyl paraben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIDOCAINE 5% CREAMLIDOCAINE 5% CREAM

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrfy.io/9BB8qYQwV7thumbnail_image0.jpg

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

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
80489-94980489-949-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLPARABENZ8IX2SC1OHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARETH-127V4MR24V5PIACT
TROLAMINE9O3K93S3TKIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-06-09full-release2026-06-01 01:34:33

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 creamDRS LIDOCAINE 5% CREAMOL PHARMA TECH LLC. (Drs. Pharmacy)372fe018-1e5a-9ec4-e063-6294a90a15002026-07-09WarningsExact identifier
ndc (package): 80489-949-01
ndc (product): 80489-949
ndc11 (package): 80489094901
spl id: 56364b0b-c371-aa7b-e063-6294a90ac8b4
spl set id: 372fe018-1e5a-9ec4-e063-6294a90a1500

Reported adverse events (FAERS/openFDA)#

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