FDA.reportPublic FDA data

Update - 85569-012-01

Manufacturer
100 KARMA INC
Effective date
2026-08-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-18 02:02:52

Label at a glance#

ProductTreatonic 5% Lidocaine Cream
Active ingredientLIDOCAINE, MENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Menthol 0.7%

OTC - PURPOSE SECTION

Local Anesthetic

DOSAGE & ADMINISTRATION SECTION

For temporary relief local discomfort,itching,pain,soreness, or burning in the perianal area associated with anorectal isorders and anorectal inflammation.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • Pregnant or breastfeeding, ask a health professional before use.
  • lf there is any allergic reaction to this product.
  • In case of accidental overdose, get medical help, or contact the poison control center immediately.

OTC - WHEN USING SECTION

Only take the recommended daily dosage unless otherwise instructed by a doctor.

Some individuals may experience allergic reactions to the ingredients contained in this produet.
Never put it into the rectum by using the finger or any medical device.

OTC - ASK DOCTOR/PHARMACIST SECTION

  • lf discomfort persists for 7 days.
  • The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Avoid contact with eyes. In case of accidental ingestion, seek medical attention immediately.

INDICATIONS & USAGE SECTION

  • For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying theproduct. Apply up to 6 times a day.
  • For children under 12 years of age: Consulta doctor.

OTHER SAFETY INFORMATION

  • Keep away from direct sunlight or heat.
  • Store at room temperature.

INACTIVE INGREDIENT SECTION

Water, Arnica, Emu Oil, Lecithin(Soybean),Propyiene Glycol, Tocopheryl Acetate, Carbomer 934, Benzyl alcohol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860014405181GTIN-13: 0860014405181
EAN-13: 0860014405181
GTIN-12: 860014405181
UPC-A: 860014405181
GTIN storage (14 digits): 00860014405181		package.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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

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
85569-01285569-012-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
LECITHIN, SOYBEAN1DI56QDM62IACT
EMU OIL344821WD61IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER 934Z135WT9208IACT
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZYL ALCOHOLLKG8494WBHIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-08full-release2026-06-01 01:34:17

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
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC47dc7630-9a74-1989-e063-6294a90a50bb2026-08-12WarningsExact identifier
ndc (package): 85569-012-01
ndc (product): 85569-012
ndc11 (package): 85569001201
spl id: 58dba06e-9265-52d7-e063-6394a90a872d
spl set id: 47dc7630-9a74-1989-e063-6294a90a50bb

Reported adverse events (FAERS/openFDA)#

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