lidocream 5

lidocream 5
SPL v2
SPL
SPL Set ID eb175796-f743-4108-b59e-d8e020d64713
Route
topical
Published
Effective Date 2015-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (5 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 5% W/W

Medication Information

Warnings

For external use only

When using this product

  • Avoid contact with the eyes 
  • Do not put in rectum
  • 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
  • rectal bleeding occurs
  • redness irritation, swelling, pain or other symptoms develop or increase
Uses

For the temporary relief of pain and itching due to anorectal disorders

Purpose

Topical Anesthetic

Directions
  • Adults when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • Apply externally to the affected area up to 6 times daily.
  • Children under 12 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 5% 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 5% W/W

Structured Label Content

Warnings

For external use only

When using this product

  • Avoid contact with the eyes 
  • Do not put in rectum
  • 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
  • rectal bleeding occurs
  • redness irritation, swelling, pain or other symptoms develop or increase
Uses

For the temporary relief of pain and itching due to anorectal disorders

Purpose

Topical Anesthetic

Directions
  • Adults when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • Apply externally to the affected area up to 6 times daily.
  • Children under 12 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 5% W/W

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:01.340957 · Updated: 2026-03-14T22:54:10.216869