Lidocaine 4 Percent Topical Cream

Lidocaine 4 Percent Topical Cream
SPL v7
SPL
SPL Set ID 4de2bc60-dc4a-4417-984f-eabab0e926a6
Route
TOPICAL
Published
Effective Date 2018-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cholesterol Hydrogenated Soybean Lecithin Polysorbate 80 Propylene Glycol Alpha-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-01
Description

LIDOCAINE 4%- lidocaine cream Marlex Pharmaceuticals, Inc. 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 4% Topical Drug Facts

Purpose

Pain & Itch Relief

Medication Information

Purpose

Pain & Itch Relief

Description

LIDOCAINE 4%- lidocaine cream Marlex Pharmaceuticals, Inc. 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 4% Topical Drug Facts

Use

for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Section 42229-5

LIDOCAINE 4%- lidocaine cream

Marlex Pharmaceuticals, Inc.

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 4% Topical

Drug Facts

Warnings

For external use only. Avoid contact with eyes. Not for prolonged use.

Do not usein large quantities, particularly over raw surfaces or blistered areas.

Directions

Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily

Children under 2 years of age:Consult a doctor

Active Ingredient

Lidocaine 4%

Other Information
  • May be applied under occlusive dressing

  • store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) 
Inactive Ingredients

Benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine and vitamin E acetate

Principal Display Panel

Lidocaine 4% Topical Anesthetic Cream

Pain & Itch Relief Cream NET WT. 0.5 oz.(15g)

Stop Use and Ask A Doctor If
  • condition worsens

  • symptoms persist for more than 7 days or clear up and occurs again within a few days

  • rash or irritation develops, persists, or increases
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Structured Label Content

Use

for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Section 42229-5 (42229-5)

LIDOCAINE 4%- lidocaine cream

Marlex Pharmaceuticals, Inc.

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 4% Topical

Drug Facts

Purpose

Pain & Itch Relief

Warnings

For external use only. Avoid contact with eyes. Not for prolonged use.

Do not usein large quantities, particularly over raw surfaces or blistered areas.

Directions

Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily

Children under 2 years of age:Consult a doctor

Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)
  • May be applied under occlusive dressing

  • store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) 
Inactive Ingredients (Inactive ingredients)

Benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine and vitamin E acetate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Lidocaine 4% Topical Anesthetic Cream

Pain & Itch Relief Cream NET WT. 0.5 oz.(15g)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens

  • symptoms persist for more than 7 days or clear up and occurs again within a few days

  • rash or irritation develops, persists, or increases
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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: 2026-02-15T12:07:13.105477 · Updated: 2026-03-14T23:10:28.026216