Indications and uses
temporarily relieves pain, itching, burning and soreness associated with hemorrhoids.
Tronolane
- Manufacturer
- New Genesis/Monticello Drug LLC | ULTRAtab Laboratories, Inc.
- Effective date
- 2018-01-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:03:49
Label at a glance#
ProductTronolane
Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC OXIDE
Label structure9 sections
Dosage and administration
Adults and children 12 years of age and older: Apply externally to the affected area up to 5 times daily. When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or cleanse by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue before application of this product. To use applicator: Remove cap from tube and attach applicato...
Storage and handling
For your protection, do not use if glue end carton or seal under cap is broken.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients | Purposes |
|---|---|
| Pramoxine hydrochloride 1% | Local anesthetic |
| Zinc oxide 5% | Astringent |
Uses
- temporarily relieves pain, itching, burning and soreness associated with hemorrhoids.
Warnings
For external use only. Certain persons can develop allergic reactions to ingredients in this product. If symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - WHEN USING SECTION
When using this product, do not exceed the recommended daily dose, unless directed by a doctor. Do not put this product in the rectum by using fingers or any mechanical device or applicator.
OTC - STOP USE SECTION
Stop use and ask a doctor if:
- bleeding occurs
- condition worsens or does not improve within 7 days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children, If swallowed, get medical help or call a Poison Control Center right away
Directions
- Adults and children 12 years of age and older: Apply externally to the affected area up to 5 times daily.
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or cleanse by patting or blotting with an appropriate cleansing pad.
- Gently dry by patting or blotting with toilet tissue before application of this product.
- To use applicator: Remove cap from tube and attach applicator. Gently squeeze tube to apply: do not insert applicator into rectum. Thoroughly cleanse applicator after use.
- Children under 12 years of age: consult a doctor.
Other information
- For your protection, do not use if glue end carton or seal under cap is broken.
Inactive ingredients
beeswax, cetyl alcohol, cetyl esthers wax, glycerin, methylparaben, propylparaben, sodium lauryl sulfate, USP water
SPL UNCLASSIFIED SECTION
Distributed by: New Genesis / Monticello Drug LLC
Jacksonville, FL 32207
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
NDC 11868-390-48
Tronolane®
Anesthetic Cream for Hemorrhoids
DUAL-ACTION
FORMULA
Rapid Relief
of Pain & Itching
Odor-free • Non-greasy • Non-staining
1 OZ (28 g)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11868-390-48 | 2023-01-05 | C162847 | 48780-1 | ba0f9c33-18f5-a910-e053-dadaa90a0b85 | Tronolane ® |
| 11868-390-59 | 2023-01-05 | C162847 | 48780-1 | ba0f9c33-18f5-a910-e053-dadaa90a0b85 | Tronolane ® |
| 11868-390-48 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-18f5-a910-e053-dadaa90a0b85 | Tronolane ® |
| 11868-390-59 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-18f5-a910-e053-dadaa90a0b85 | Tronolane ® |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PRAMOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 88AYB867L5 | 5 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 5 | |
| PRAMOXINE | ACTIVE MOIETY | 068X84E056 | 5 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 5 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 5 | |
| CETYL ESTERS WAX | INACTIVE INGREDIENT | D072FFP9GU | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 5 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 5 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 5 |
Products#
Every source-derived product name is available through these pages.
- Tronolane
- Pramoxine HCl
- PRAMOXINE HYDROCHLORIDE
- PRAMOXINE
- ZINC OXIDE
- ZINC CATION
- YELLOW WAX
- CETYL ALCOHOL
- CETYL ESTERS WAX
- GLYCERIN
- METHYLPARABEN
- PROPYLPARABEN
- SODIUM LAURYL SULFATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11868-390 | 11868-390-28, 11868-390-48, 11868-390-58, 11868-390-59 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PRAMOXINE HYDROCHLORIDE | 88AYB867L5 | ACTIB |
| ZINC OXIDE | SOI2LOH54Z | ACTIM |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| CETYL ESTERS WAX | D072FFP9GU | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PELLET / ORAL | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SPONGE / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, ORALLY DISINTEGRATING / ORAL | 9 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FILM COATED / ORAL | 240 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | GRANULE / ORAL | 12 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / VAGINAL | 12 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | INSERT / VAGINAL | 15 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, DELAYED RELEASE / ORAL | 199 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EFFERVESCENT / ORAL | 1.5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAVENOUS | 6 mg | ||
| CETYL ESTERS WAX | CETYL ESTERS WAX | D072FFP9GU | LOTION / TOPICAL | 1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / NASAL | 0.2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE / ORAL | 600 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 59 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / VAGINAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | GEL / DENTAL | 1.47 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EXTENDED RELEASE / ORAL | 320 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| f18b44ea-5d2e-6043-e053-2a95a90afbac | 0d5ba4f1-1178-490d-8524-143d0aa2f0ef | 2023-01-05 | Warnings | 0d5ba4f1-1178-490d-8524-143d0aa2f0ef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.