Indications and uses
For the temporary relief of local and anorectal itching , discomfortand pain associated with anorectal disorder or anorectal inflammation.
LIDOCAINE
- Manufacturer
- Sichuan Gumo Brand Management Co.,Ltd
- Effective date
- 2023-04-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:54:44
Label at a glance#
ProductLIDOCAINE
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections
Dosage and administration
Cleanse the affected area. Sensitivity and possible allergy tests advised prior to use Spray sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs . You may reapply to continue numbing effect. apply to the affected area up to 4 times daily. children under 12 years of age: consult a doctor.
Storage and handling
Keep away from direct sunlight or heat. store in room temperature (59-86F/15-30C)
Label contents#
Full prescribing information#
Active Ingredient
Lidocaine Hcl 5%
Phenylephrine Hcl 0.25%
Purpose
Local Anesthetic
Vasoconstrictor
Uses
For the temporary relief of local and anorectal itching , discomfortand pain associated with anorectal disorder or anorectal inflammation.
Warnings
Do not use this product if :
pregnant or breastfeeding, ask a health professional before use.
tamper-evident " Do not se this product if seal is broken or missing.
you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.
Do not use
Do not use this product if :
pregnant or breastfeeding, ask a health professional before use.
tamper-evident " Do not se this product if seal is broken or missing.
you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.
When using
When using this product
do not exceed the recommended the daily usage.
certain persons can develop allergic reactions to ingredients in this product.
do nut put this product into the rectum by using finger or any medical device or applicator.
If swallowed, call your Poison Control Center immediately. If condition worsens or does not improve within 7 days, consult a doctor
Stop use
Stop use and ask a doctor if
The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.
Directions
Cleanse the affected area.
Sensitivity and possible allergy tests advised prior to use Spray sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs . You may reapply to continue numbing effect.
apply to the affected area up to 4 times daily.
children under 12 years of age: consult a doctor.
Other Information
Keep away from direct sunlight or heat.
store in room temperature (59-86F/15-30C)
Inactive Ingredients
Allantoin, Arginline, Benzyl Alcohol, Disodium EDTA , Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite
Keep Out Of
Keep Out Of Reach Of Children If Swallowed .Get Medical Help Or Contact A Poison Control Center Right Away
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83365-002-01 | 2024-07-30 | C162847 | 48780-1 | 1030e365-58f4-111a-e063-dadaa90a10e2 | 83365-001 |
| 83365-002-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-58f4-111a-e063-dadaa90a10e2 | 83365-001 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83365-002-01 | LIDOCAINE | 141 g in 1 BOX | SPRAY | 141 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- LIDOCAINE
- LIDOCAINE spray
- PHENOXYETHANOL
- POLYSORBATE 20
- SODIUM BENZOATE
- BENZYL ALCOHOL
- EDETATE DISODIUM ANHYDROUS
- WATER
- SODIUM SULFITE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- DIETHYLENE GLYCOL MONOETHYL ETHER
- ARGININE
- ALLANTOIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83365-002 | 83365-002-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| EDETATE DISODIUM ANHYDROUS | 8NLQ36F6MM | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM SULFITE | VTK01UQK3G | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| DIETHYLENE GLYCOL MONOETHYL ETHER | A1A1I8X02B | IACT |
| ARGININE | 94ZLA3W45F | IACT |
| ALLANTOIN | 344S277G0Z | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| f9a7f08e-9e00-b9d2-e053-6394a90a8582 | f9a7f08e-9dff-b9d2-e053-6394a90a8582 | 2023-04-18 | Warnings | f9a7f08e-9e00-b9d2-e053-6394a90a8582 f9a7f08e-9dff-b9d2-e053-6394a90a8582 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.