2.0% Lidocaine Burn Spray

SPL v1

SPL

SPL Set ID e1911279-85f7-4053-b6da-8f4e991347a2

Route

TOPICAL

Published

Effective Date 2026-01-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

Aminomethylpropanol Glycerin Hypromellose, Unspecified Tea Tree Oil Octoxynol-9 Polyoxyl 40 Hydrogenated Castor Oil Phenoxyethanol Propylene Glycol Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2026-01-19

Description

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Medication Information

Purpose

Topical pain relief

Description

Lidocaine HCl 2.0%

Section 42229-5

✓ Instant Cooling Relief

✓ Soothes Minor Burns & Sunburns

Store at 68°-77°F (20°-25°C)

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road,

Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Section 50565-1

Keep out of reach of children. if swallowed get medical help or contact a Poison Control Center right away.

uses

Temporary pain relief associated with minor burns

Packaging

purpose

Topical pain relief

warnings

For external use only.

Do not use • in large quantities, particularly over raw or blistered area • near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor if the condition worsens or persists for more than 7 days or clears up and returns.

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

drug Facts

Inactive Ingredients

AMINOMETHYL PROPANOL, GLYCERIN, HYDROXYPROPYL METHYLCELLULOSE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, OCTOXYNOL-9, PEG-40 HYDROGENATED CASTOR OIL, PHENOXYETHANOL, PROPYLENE GLYCOL, WATER

active Ingredient

Lidocaine HCl 2.0%

Structured Label Content

Section 42229-5 (42229-5)

✓ Instant Cooling Relief

✓ Soothes Minor Burns & Sunburns

Store at 68°-77°F (20°-25°C)

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road,

Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Section 50565-1 (50565-1)

Keep out of reach of children. if swallowed get medical help or contact a Poison Control Center right away.

uses (Uses)

Temporary pain relief associated with minor burns

Packaging

purpose (Purpose)

Topical pain relief

warnings (Warnings)

For external use only.

Do not use • in large quantities, particularly over raw or blistered area • near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor if the condition worsens or persists for more than 7 days or clears up and returns.

directions (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

drug Facts (Drug Facts)

Inactive Ingredients (Inactive ingredients)

AMINOMETHYL PROPANOL, GLYCERIN, HYDROXYPROPYL METHYLCELLULOSE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, OCTOXYNOL-9, PEG-40 HYDROGENATED CASTOR OIL, PHENOXYETHANOL, PROPYLENE GLYCOL, WATER

active Ingredient (Active ingredient)

Lidocaine HCl 2.0%

Advanced Ingredient Data

[{"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTOXYNOL-9", "unii": "7JPC6Y25QS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"42229-5": "✓ Instant Cooling Relief ✓ Soothes Minor Burns & Sunburns Store at 68°-77°F (20°-25°C) Mfd for and Distributed by: Universal Distribution Center LLC 330 Applegarth Road, Monroe Township, NJ 08831 www.universaldc.com MADE IN CHINA", "50565-1": "Keep out of reach of children. if swallowed get medical help or contact a Poison Control Center right away.", "Uses": "Temporary pain relief associated with minor burns", "Purpose": "Topical pain relief", "Warnings": "For external use only. Do not use • in large quantities, particularly over raw or blistered area • near eyes, if this happens rinse thoroughly with water Stop use and ask a doctor if the condition worsens or persists for more than 7 days or clears up and returns.", "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", "Inactive ingredients": "AMINOMETHYL PROPANOL, GLYCERIN, HYDROXYPROPYL METHYLCELLULOSE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, OCTOXYNOL-9, PEG-40 HYDROGENATED CASTOR OIL, PHENOXYETHANOL, PROPYLENE GLYCOL, WATER", "Active ingredient": "Lidocaine HCl 2.0%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:21.270414 · Updated: 2026-03-14T23:12:34.529887