SPL v3
SPL
SPL Set ID 6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e
Route
TOPICAL
Published
Effective Date 2018-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Aloe Vera Leaf Calendula Officinalis Flower Camellia Sinensis Flower Matricaria Chamomilla Whole Diazolidinyl Urea Edetate Disodium Glycerin Menthol Methylparaben Propylene Glycol Propylparaben Water Alcohol Comfrey Leaf Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-03-29
Description

Lidocaine 4%

Purpose

Topical Anesthetic

Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

For the temporary relief of discomfort and pain

Section 50566-9
  • skin becomes irritated
  • condition worsens or symptoms last more than 7 days
  • symptoms clear up and reoccur within a few days
Warnings

For external use only

Avoid contact with eyes

Directions

Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily

Do Not Use

In large quantities, particularly over raw surfaces or blistered areas

Distributed By:

Universal Companies, Inc. Abingdon, VA 24210

Active Ingredients

Lidocaine 4%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Plum Smooth Plumb Numb Gelee 1oz/28.35g

Structured Label Content

Uses

For the temporary relief of discomfort and pain

Section 50566-9 (50566-9)
  • skin becomes irritated
  • condition worsens or symptoms last more than 7 days
  • symptoms clear up and reoccur within a few days
Purpose

Topical Anesthetic

Warnings

For external use only

Avoid contact with eyes

Directions

Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily

Do Not Use (Do not use)

In large quantities, particularly over raw surfaces or blistered areas

Distributed By: (Distributed by:)

Universal Companies, Inc. Abingdon, VA 24210

Active Ingredients

Lidocaine 4%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Plum Smooth Plumb Numb Gelee 1oz/28.35g

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:18.226157 · Updated: 2026-03-14T23:01:46.594887