2% Tetracaine Gel

2% Tetracaine Gel
SPL v3
SPL
SPL Set ID 60cabb5f-606b-7a74-e053-2a91aa0ac024
Route
TOPICAL
Published
Effective Date 2017-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetracaine (20 mg)
Inactive Ingredients
Hydroxyethyl Cellulose (100 Mpa.s At 2%) Caprylyl Glycol Edetic Acid Glycerin Propylene Glycol Phenoxyethanol Water Aloe Vera Leaf Sorbic Acid

Identifiers & Packaging

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

Tetracaine HCL 2%

Medication Information

Warnings and Precautions

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

DO NOT USE : In large quantities, particularly over raw surfaces and blistered areas.

Stop use and ask a doctor if:

  • Skin becomes irritated
  • Condition worsens or symptoms last more than 7 days
  • Symptoms clear up and reoccur within a few days.
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

Tetracaine HCL 2%

Section 50565-1

Keep out of reach of children.

Section 51727-6

Water, Glycerin, Propylene Glycol, Hydroxyethyl Cellulose, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

Tetracaine HCL 2%

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 surfaces and blistered areas.

Stop use and ask a doctor if:

  • Skin becomes irritated
  • Condition worsens or symptoms last more than 7 days
  • Symptoms clear up and reoccur within a few days.
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Water, Glycerin, Propylene Glycol, Hydroxyethyl Cellulose, 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)

Tetracaine HCL 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:27.484167 · Updated: 2026-03-14T23:05:12.885917