SMART Numb Lidocaine Cream
- Manufacturer
- M.J. Winston International, Ltd.
- Effective date
- 2025-08-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:40:05
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
WARNINGS SECTION
WARNINGS
For external use only.
Stop use and ask a doctor if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop. If pregnant or breast-feeding, ask a health professional before use.
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Keep out of reach of children.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Lidocaine 5% local anesthetic
OTC - PURPOSE SECTION
Use
For the temporary relief of pain, burning, and soreness associted with anorectal discomfort or inflammation.
OTC - WHEN USING SECTION
When using this product
Do not excceed recommended dosage unless directed by a doctor.
INSTRUCTIONS FOR USE SECTION
Directions
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. For products for external use only. Apply up to 6 times a day. Children under 12 years of age: consult a doctor.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Aacrylates, Allantoin, Arnice Montana Flower Extract, Deionized Water, Dimethyl Isosorbide, Emu Oil, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polydecene, Menthol, Phenoxythanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium Edta, Tocopheryl Acetate, Trideceth-6
OTHER SAFETY INFORMATION
Other Information
Store at 59F to 86F (15C to 30C). Keep away from direct sunlight.
OTC - QUESTIONS SECTION
Questions or concerns?
Contact info@smartmed.us or 714-582-2715.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
INDICATIONS & USAGE SECTION
Use
For the temporary relief of pain, burning, and soreness associated with anorectal discomfort or inflammation.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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 |
Products#
Every source-derived product name is available through these pages.
- SMART Numb Lidocaine Cream
- lidocaine
- PROPYLENE GLYCOL
- ARNICA MONTANA FLOWER
- MENTHOL
- TRIDECETH-6
- ETHYLHEXYLGLYCERIN
- PHENOXYETHANOL
- SUNFLOWER OIL
- EDETATE SODIUM
- SODIUM POLYACRYLATE (2500000 MW)
- HYDROGENATED POLYDECENE (1500 CST)
- WATER
- DIMETHYL ISOSORBIDE
- EMU OIL
- ALLANTOIN
- .ALPHA.-TOCOPHEROL ACETATE, D-
- ETHYLHEXYL PALMITATE
- ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76092-201 | 76092-201-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 4f0c2bf4-126d-bc56-e063-6294a90a024f | 1138c88a-447c-644e-e063-6294a90aab3f | 2026-04-09 | Warnings | 1138c88a-447c-644e-e063-6294a90aab3f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.









