78495-142

78495-142
SPL v2
SPL
SPL Set ID b6f288f7-9ae3-215e-e053-2a95a90aedf6
Route
TOPICAL
Published
Effective Date 2020-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Glycerin Octoxynol-9 Phenoxyethanol Propylene Glycol Trolamine Hypromelloses Tea Tree Oil Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-19
Description

Lidocaine HCI 2.0%

Purpose

Topical pain relief

Medication Information

Purpose

Topical pain relief

Description

Lidocaine HCI 2.0%

Uses

Temporary pain relief associated with minor burns

Section 42229-5

Topical Analgesic

Relieves pain in minor burns

Store at 68°-77°F (20°-25°C)

Section 51945-4

Warnings

For external use only.

Directions
  • spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • not to be used on Children under 12 years of age

Do Not Use
  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water
Active Ingredient

Lidocaine HCI 2.0%

Inactive Ingredients

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9,PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Questions Or Comments?

1-800-634-7680

Stop Use and Ask A Doctor

if condition worsens or persists for more than 7 days or clears up and returns.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

Temporary pain relief associated with minor burns

Section 42229-5 (42229-5)

Topical Analgesic

Relieves pain in minor burns

Store at 68°-77°F (20°-25°C)

Section 51945-4 (51945-4)

Purpose

Topical pain relief

Warnings

For external use only.

Directions
  • spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • not to be used on Children under 12 years of age

Do Not Use (Do not use)
  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water
Active Ingredient (Active ingredient)

Lidocaine HCI 2.0%

Inactive Ingredients (Inactive ingredients)

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9,PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Questions Or Comments? (Questions or comments?)

1-800-634-7680

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if condition worsens or persists for more than 7 days or clears up and returns.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:52.174867 · Updated: 2026-03-14T23:08:14.770901