4% Lidocaine Gel

4% Lidocaine Gel
SPL v3
SPL
SPL Set ID 60cb89f6-e326-0773-e053-2a91aa0a33dd
Route
TOPICAL
Published
Effective Date 2017-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Alcohol Glycerin Propylene Glycol Xanthan Gum Aloe Vera Leaf Caprylyl Glycol Phenoxyethanol Sorbic Acid Edetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-01
Description

Lidocaine 4%

Medication Information

Warnings and Precautions

WARNINGS: For external use only. Avoid contact with the eyes.

DO NOT USE: In large quantities particularly over raw sources or blistered areas.

Indications and Usage

USES: For the temporary relief of discomfort and pain associated with

  • Minor burns and skin irritations
  • Minor cuts and scrapes
  • Itching

DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.

Dosage and Administration

USES: For the temporary relief of discomfort and pain associated with

  • Minor burns and skin irritations
  • Minor cuts and scrapes
  • Itching

DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.

Description

Lidocaine 4%

Section 50565-1

Keep put of reach of children.

Section 51727-6

Water, Ethyl Alcohol, Glycerin, Propylene Glycol, Xanthan Gum, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA.

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 4%

Structured Label Content

Indications and Usage (34067-9)

USES: For the temporary relief of discomfort and pain associated with

  • Minor burns and skin irritations
  • Minor cuts and scrapes
  • Itching

DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.

Dosage and Administration (34068-7)

USES: For the temporary relief of discomfort and pain associated with

  • Minor burns and skin irritations
  • Minor cuts and scrapes
  • Itching

DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.

Warnings and Precautions (34071-1)

WARNINGS: For external use only. Avoid contact with the eyes.

DO NOT USE: In large quantities particularly over raw sources or blistered areas.

Section 50565-1 (50565-1)

Keep put of reach of children.

Section 51727-6 (51727-6)

Water, Ethyl Alcohol, Glycerin, Propylene Glycol, Xanthan Gum, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:27.486267 · Updated: 2026-03-14T23:05:12.885917