Lidocream 4

Lidocream 4
SPL v2
SPL
SPL Set ID bfac34cc-05bd-46fb-9fb0-c15bc31c76be
Route
TOPICAL
Published
Effective Date 2015-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Aloe Vera Leaf Benzyl Alcohol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetate Disodium Glycerin Glyceryl Oleate Alcohol Simmondsia Chinensis Seed Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-12-01
Description

Lidocaine 4% W/W

Purpose

Topical Anesthetic

Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4% W/W

Uses

For the temporary relief of pain and itching due to

  • minor burns
  • minor skin irritations
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only

When using this product

  • Avoid contact with the eyes 
  • Do not use in large quantities particularly over raw surfaces or blistered areas.
  • Do not exceed recommended dosage unless directed by a doctor



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
  • notice any unusual effects such as blurred vision, dizziness or drowsiness, difficulty in breathing, trembling, chest pain or irregular heart beat
Packaging

Directions
  • Adults and children 2 years and older: apply externally to the affected area not more than 3 to 4 times daily   
  • Children under 2 years of age: consult a doctor 
Active Ingredient

Lidocaine 4% W/W

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

Structured Label Content

Uses

For the temporary relief of pain and itching due to

  • minor burns
  • minor skin irritations
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Topical Anesthetic

Warnings

For external use only

When using this product

  • Avoid contact with the eyes 
  • Do not use in large quantities particularly over raw surfaces or blistered areas.
  • Do not exceed recommended dosage unless directed by a doctor



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
  • notice any unusual effects such as blurred vision, dizziness or drowsiness, difficulty in breathing, trembling, chest pain or irregular heart beat
Packaging

Directions
  • Adults and children 2 years and older: apply externally to the 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% W/W

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:01.335998 · Updated: 2026-03-14T22:54:10.216869