lidocaine 4% topical anesthetic cream with vit e

lidocaine 4% topical anesthetic cream with vit e
SPL v5
SPL
SPL Set ID a70863f0-48c1-5e6f-e053-2995a90a9606
Route
topical
Published
Effective Date 2020-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (2 g)
Inactive Ingredients
polysorbate 80 water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-06-15
Purpose

Topical Anesthetic Uses temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites

Description

Lidocaine 4% w/w

Medication Information

Warnings

For external use only

Purpose

Topical Anesthetic

Uses temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
    • sunburn
    • minor skin irritations
    • minor burns
    • insect bites
Directions
  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
  • Children under 2 years of age: consult a doctor
Other Information
  • Store at USP controlled room temperature 20-25 oC (68-77 oF).
Inactive Ingredients

benzyl alcohol, cabomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water

Description

Lidocaine 4% w/w

Usage
  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
  • Children under 2 years of age: consult a doctor
Dosage

40 milligrams/gram per application

Package Label

Active Ingredients

Lidocaine 4% w/w

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

Structured Label Content

Warnings

For external use only

Purpose

Topical Anesthetic

Uses temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
    • sunburn
    • minor skin irritations
    • minor burns
    • insect bites
Directions
  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
  • Children under 2 years of age: consult a doctor
Other Information (Other information)
  • Store at USP controlled room temperature 20-25 oC (68-77 oF).
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, cabomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water

Usage
  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
  • Children under 2 years of age: consult a doctor
Dosage

40 milligrams/gram per application

Package Label

Active Ingredients

Lidocaine 4% w/w

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 (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: 2026-02-15T12:06:34.880149 · Updated: 2026-03-14T23:09:26.831955