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#
Contacts and useful links#
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
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0860014405181 | GTIN-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 | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- Treatonic 5% Lidocaine Cream
- 5% Lidocaine Cream
- LIDOCAINE
- PROPYLENE GLYCOL
- LECITHIN, SOYBEAN
- ALPHA-TOCOPHEROL ACETATE
- MENTHOL
- EMU OIL
- WATER
- BENZYL ALCOHOL
- CARBOMER
- ARNICA MONTANA FLOWER WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85569-014 | 85569-014-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIDOCAINE | 98PI200987 | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| ALPHA-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| EMU OIL | 344821WD61 | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CARBOMER | 0A5MM307FC | IACT |
| ARNICA MONTANA FLOWER WATER | U7L2JP51PR | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-02-03 | full-release | 2026-06-01 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Treatonic 5% Lidocaine Cream | 5% LIDOCAINE CREAM | 100 KARMA INC | 49e6b69f-bd6e-b415-e063-6394a90a8e65 | 2026-08-12 | Warnings | 85569-014-01 85569-014 85569001401 58dba5f4-60c1-55e2-e063-6394a90ac2d7 49e6b69f-bd6e-b415-e063-6394a90a8e65 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
