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
Purpose

Topical Anesthetic

Description

Lidocaine 4% W/W

Medication Information

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
Uses

For the temporary relief of pain and itching due to

  • minor burns
  • minor skin irritations
Purpose

Topical Anesthetic

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 
Inactive Ingredients

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

Description

Lidocaine 4% W/W

Section 50565-1

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

Packaging

Active Ingredient

Lidocaine 4% W/W

Structured Label Content

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
Uses

For the temporary relief of pain and itching due to

  • minor burns
  • minor skin irritations
Purpose

Topical Anesthetic

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 
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

Section 50565-1 (50565-1)

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

Packaging

Active Ingredient (Active ingredient)

Lidocaine 4% W/W

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