Lidocaine 4 Percent Cream

Lidocaine 4 Percent Cream
SPL v2
SPL
SPL Set ID 651710db-3c50-4bcf-b7cc-9ed24f663427
Route
TOPICAL
Published
Effective Date 2024-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01
Description

LIDOCAINE - L idocaine  HCl 4%   C ream SA3, LLC   Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Lidocaine HCl 4% Topical Analgesic Cream ​Drug Facts

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

LIDOCAINE - L idocaine  HCl 4%   C ream SA3, LLC   Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Lidocaine HCl 4% Topical Analgesic Cream ​Drug Facts

Uses

Temporarily relieves pain and itching due to:

  • minor cuts

  • sunburn

  • minor scrapes

  • minor burns

  • insect bites

  • minor skin irritations
Section 42229-5

LIDOCAINE - L idocaine  HCl 4%   C ream

SA3, LLC  

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Lidocaine HCl 4% Topical Analgesic Cream

​Drug Facts

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.

Principal Display Panel

Lidocaine HCl 4%   cream

NDC 69420-6262-1 

Topical Analgesic Cream

4.2 OZ ( 120 g )

SA3, LLC

When Using This Product
  • Avoid contact with the eyes

  • D o not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask A Doctor
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • If allergic reaction occurs or if 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.

Structured Label Content

Uses

Temporarily relieves pain and itching due to:

  • minor cuts

  • sunburn

  • minor scrapes

  • minor burns

  • insect bites

  • minor skin irritations
Section 42229-5 (42229-5)

LIDOCAINE - L idocaine  HCl 4%   C ream

SA3, LLC  

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Lidocaine HCl 4% Topical Analgesic Cream

​Drug Facts

Purpose

Topical Analgesic

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 (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 (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Lidocaine HCl 4%   cream

NDC 69420-6262-1 

Topical Analgesic Cream

4.2 OZ ( 120 g )

SA3, LLC

When Using This Product (When using this product)
  • Avoid contact with the eyes

  • D o not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • If allergic reaction occurs or if redness, irritation, swelling, pain or other symptoms begin or increase.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:38.499536 · Updated: 2026-03-14T23:05:32.543899