Lidocaine Cream

Lidocaine Cream
SPL v3
SPL
SPL Set ID 43705a1f-76ef-48d1-aa1a-c7b439266caa
Route
TOPICAL
Published
Effective Date 2017-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Arnica Montana Flower Indian Frankincense Cetostearyl Alcohol Chondroitin Sulfate (bovine) Dimethyl Sulfone Ethylhexylglycerin Glucosamine Sulfate Glycerin Glyceryl 1-stearate C13-14 Isoparaffin Isostearyl Palmitate Laureth-7 Peg-100 Stearate Phenoxyethanol Polyacrylamide (10000 Mw) Propylene Glycol Sodium Polyacrylate (2500000 Mw) Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-01
Description

Lidocaine HCl 4% w/w

Purpose

Topical anesthetic

Medication Information

Purpose

Topical anesthetic

Description

Lidocaine HCl 4% w/w

Uses

temporarily relieves pain and itching due to:

  • •
    minor cuts
  • •
    sunburn
  • •
    minor scrapes
  • •
    minor burns
  • •
    insect bites
  • •
    minor skin irritations
Warnings

For external use only.

Directions

adults and children 2 years and older: apply externally to the affected area up to 3 to 4 times a day

children under 2 years: ask a doctor

Active Ingredient

Lidocaine HCl 4% w/w

Other Information
  • •
    May be applied under occlusive dressing.
  • •
    Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

When Using This Product
  • •
    do not use in or near the eyes
  • •
    do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask A Doctor If
  • •
    allergic reaction occurs
  • •
    condition worsens or does not improve within 7 days
  • •
    symptoms clear up and return within a few days
  • •
    redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

LIDOCAINE 4%

Topical Anesthetic Cream

120 grams

NDC: 50488-6262-1

Manufactured for: Alexso Inc.

2317 Cotner Avenue Los Angeles, CA 90064

Tel: 888.495.6078 Web: www.alexso.com

Label

Structured Label Content

Uses

temporarily relieves pain and itching due to:

  • •
    minor cuts
  • •
    sunburn
  • •
    minor scrapes
  • •
    minor burns
  • •
    insect bites
  • •
    minor skin irritations
Purpose

Topical anesthetic

Warnings

For external use only.

Directions

adults and children 2 years and older: apply externally to the affected area up to 3 to 4 times a day

children under 2 years: ask a doctor

Active Ingredient (Active ingredient)

Lidocaine HCl 4% w/w

Other Information
  • •
    May be applied under occlusive dressing.
  • •
    Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

When Using This Product (When Using this Product)
  • •
    do not use in or near the eyes
  • •
    do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask A Doctor If (Stop Use and Ask a Doctor If)
  • •
    allergic reaction occurs
  • •
    condition worsens or does not improve within 7 days
  • •
    symptoms clear up and return within a few days
  • •
    redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

LIDOCAINE 4%

Topical Anesthetic Cream

120 grams

NDC: 50488-6262-1

Manufactured for: Alexso Inc.

2317 Cotner Avenue Los Angeles, CA 90064

Tel: 888.495.6078 Web: www.alexso.com

Label

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:45.565538 · Updated: 2026-03-14T22:55:26.303656