Indications and uses
for the temporary relief of local and anorectal itching, discomfort, and pain associated with anorectal disorders or anorectal inflammation.
Numb520 SPRAY
- Manufacturer
- Clinical Resolution Laboratory, Inc.
- Effective date
- 2025-05-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:10
Label at a glance#
ProductNumb520
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure7 sections
Dosage and administration
clean 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.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Lidocaine 5%
Phenylephrine HCL 0.25%
Purpose
Local Anesthetic
Vasoconstrictor
Uses:
for the temporary relief of local and anorectal itching, discomfort, and pain associated with anorectal disorders or anorectal inflammation.
Warnings
- for external use only.
- avoid contact with the eyes.
keep out of reach of children.
Do not use
this product if
- pregnant or breastfeeding, ask a health professional before use.
- 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 this product
- do not exceed the recommended daily usage.
- certain persons can develop allergic reactions to ingredients in this product.
- do not put this product into the rectum by using finger or any medical device or applicator.
- if swallowed, call your Poison Control Center at 1(800) 222 1222.
- If condition worsens or does not improve within 7 days, consult a doctor.
Stop use and ask a doctor if
- the symptom being treated does not subside, or redness, irritation, swelling, pain, or other symptoms develop or increase.
Directions
- clean 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 at room temperature 15°-30°C (59°-86°F).
Inactive Ingredients
Allantoin, Arginine, Benzyl Alcohol, Disodium EDTA, Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Water, Sodium Benzoate, Sodium Sulfite
Package Labeling:
DailyMed RxNorm Mappings#
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63742-034-01 | Numb520 | 72 mL in 1 BOTTLE | SPRAY | 72 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Numb520
- LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
- ALLANTOIN
- ARGININE
- BENZYL ALCOHOL
- EDETATE DISODIUM ANHYDROUS
- DIETHYLENE GLYCOL MONOETHYL ETHER
- PHENOXYETHANOL
- POLYSORBATE 20
- WATER
- SODIUM BENZOATE
- SODIUM SULFITE
- LIDOCAINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63742-034 | 63742-034-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALLANTOIN | 344S277G0Z | IACT |
| ARGININE | 94ZLA3W45F | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| EDETATE DISODIUM ANHYDROUS | 8NLQ36F6MM | IACT |
| DIETHYLENE GLYCOL MONOETHYL ETHER | A1A1I8X02B | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM SULFITE | VTK01UQK3G | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
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 |
|---|---|---|---|---|---|---|
| Numb520 | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | Clinical Resolution Laboratory, Inc. | 65d3b614-361d-4fb9-9583-a95be754bc82 | 2025-05-15 | Warnings | 63742-034-01 63742-034 63742003401 353212d3-630c-14b4-e063-6394a90a5b29 65d3b614-361d-4fb9-9583-a95be754bc82 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.