OTC - ACTIVE INGREDIENT SECTION
- Lidocaine 5%
- Phenylephrine HCI 0.25%
Update - 85569-008-01
- Manufacturer
- 100 KARMA INC
- Effective date
- 2026-08-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-08-15 01:00:44
Label at a glance#
ProductTreatonic hemorrhoid treatment
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
- Topical anesthetic
- Vasoconstrictor
DOSAGE & ADMINISTRATION SECTION
- For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.
- For the temporary reliefofpain, burning and soreness.
- Temporarily shrinks hemorrhoidal tissue.
- Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.
WARNINGS SECTION
For external and / or intrarectal use only.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
OTC - DO NOT USE SECTION
- Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
- Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain.
- Consult a doctor promptly.
OTC - STOP USE SECTION
- lf the 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.
- Certain persons can develop allergic reactions to ingredients in this product.
- If the symptombeing treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children, if swallowed, get medical help or contact poison control center 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 or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
- For External use: Apply externally to the affected area up to 4 times daily.
- For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.
OTHER SAFETY INFORMATION
- Keep away from direct sunlight or heat.
- Store at room temperature 15°-30°C(59°-86°F).
- This package is child-resistant. Keep out of reach of children.
- In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
INACTIVE INGREDIENT SECTION
Water, Ethylhexyl Palmitate, Zinc Oxide, Glycerin, Propylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, Gentiana Scabra Root Extract, Centella Asiatica Extract, Menthol, PEG-100 Stearate, Carbomer, Allantoin, Salvia Miltiorrhiza Root Extract, Angelica Polymorpha Sinensis Root Extract, Eugenia Caryophyllus (Clove) Bud Extract, Glycyrrhiza Uralensis (Licorice) Root
Extract, Dendrobium Officinale Stem Extract, Stephania Tetrandra Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Taxus Cuspidata Leaf Extract, Smilax Glabra Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Potassium Alum, Caprylhydroxamic Acid, Phenoxyethanol.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0860014405129 | GTIN-13: 0860014405129 EAN-13: 0860014405129 GTIN-12: 860014405129 UPC-A: 860014405129 GTIN storage (14 digits): 00860014405129 | package.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Treatonic hemorrhoid treatment
- 5% lidocaine
- LIDOCAINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- GLYCERIN
- CENTELLA ASIATICA
- ANGELICA SINENSIS ROOT
- CLOVE
- SMILAX GLABRA WHOLE
- GLYCERYL STEARATE
- PEG-100 STEARATE
- STEPHANIA TETRANDRA ROOT
- GLYCYRRHIZA GLABRA (LICORICE) ROOT
- MENTHOL
- HORSE CHESTNUT
- POTASSIUM ALUM
- CAPRYLHYDROXAMIC ACID
- CARBOMER
- SALVIA MILTIORRHIZA ROOT
- ETHYLHEXYL PALMITATE
- ALLANTOIN
- GENTIANA SCABRA ROOT
- GLYCYRRHIZA URALENSIS ROOT
- WATER
- DENDROBIUM OFFICINALE STEM
- PHENOXYETHANOL
- TAXUS CUSPIDATA LEAF
- ZINC OXIDE
- PROPYLENE GLYCOL
- CAPRYLIC/CAPRIC TRIGLYCERIDE
- CETEARYL ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85569-008 | 85569-008-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-10-16 | full-release | 2026-06-01 01:41:15 |
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 hemorrhoid treatment | 5% LIDOCAINE | 100 KARMA INC | 41442fa7-c511-07ca-e063-6294a90a3992 | 2026-08-12 | Warnings | 85569-008-01 85569-008 85569000801 58db951c-2398-4a7c-e063-6394a90a02c6 41442fa7-c511-07ca-e063-6294a90a3992 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.