Update 85569-014-01

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 02:02:20

Label at a glance#

ProductTreatonic 5% Lidocaine Cream
Active ingredientLIDOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

OTC - PURPOSE SECTION

Local Anorectal

(hemorrhoidal) Anesthetic

DOSAGE & ADMINISTRATION SECTION

For the temporary relief of local itching and discomfort associated withe anorectal disorders.

For the temporary relief of pain, burning and soreness.

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

  • IF condition worsens or does not improve within 7 days, consult a doctor.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • In case of bleeding, consult a doctor promptly.
  • Do no t put this product into the rectum by using fingers or any mechanical device or applicatior.

OTC - ASK DOCTOR/PHARMACIST SECTION

  • An allergic reaction occurs
  • Symptom does not improve or if redness, irritation, swelling, pain or other symptom develop or increase.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, Gently dry by patting o rblotting with toilet tissue or a soft clothbefore application of this product.
  • Apply to the affected area up to 6 times daily.
  • Chlldren under 12 years of age: consulta doctor.

OTHER SAFETY INFORMATION

Store at room temperature 59°- 86°F (15°-30°C). Keep away from direct sunlight or heat.

INACTIVE INGREDIENT SECTION

Water, Arnica Montana Flower Extract, Emu Oil,Lecithin, Propylene Glycol, Tocopheryl Acetate,Carbomer, Menthol, Benzyl Alcohol.

OTC - QUESTIONS SECTION

Contact us at service@treatonic.com

Tel: +1 (917)-539-7295

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
85569-01485569-014-01

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
12026-02-03full-release2026-06-01 01:47:08

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 INC49e6b69f-bd6e-b415-e063-6394a90a8e652026-08-12WarningsExact identifier
ndc (package): 85569-014-01
ndc (product): 85569-014
ndc11 (package): 85569001401
spl id: 58dba5f4-60c1-55e2-e063-6394a90ac2d7
spl set id: 49e6b69f-bd6e-b415-e063-6394a90a8e65

Reported adverse events (FAERS/openFDA)#

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