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#

ProductSMART Numb Lidocaine Cream
Active ingredientLIDOCAINE
Label structure12 sections

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.

WARNINGSWARNINGS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Lidocaine 5% local anesthetic

activeactive

OTC - PURPOSE SECTION

Use

For the temporary relief of pain, burning, and soreness associted with anorectal discomfort or inflammation.

useuse

OTC - WHEN USING SECTION

When using this product

Do not excceed recommended dosage unless directed by a doctor.

when using this productwhen using this product

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.

directionsdirections

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

inactiveinactive

OTHER SAFETY INFORMATION

Other Information

Store at 59F to 86F (15C to 30C). Keep away from direct sunlight.

other infoother info

OTC - QUESTIONS SECTION

Questions or concerns?

Contact info@smartmed.us or 714-582-2715.

questionsquestions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

keep out of reach of childrenkeep out of reach of children

DOSAGE & ADMINISTRATION SECTION

dosage administrationdosage administration

INDICATIONS & USAGE SECTION

Use

For the temporary relief of pain, burning, and soreness associated with anorectal discomfort or inflammation.

indicationindication

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label principalpackage label principal

DailyMed Product Concepts#

Product concept, Relation, Version table
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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76092-20176092-201-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4f0c2bf4-126d-bc56-e063-6294a90a024f1138c88a-447c-644e-e063-6294a90aab3f2026-04-09WarningsExact identifier
spl set id: 1138c88a-447c-644e-e063-6294a90aab3f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.