43473-070 Ligthning Products Burn Spray

SPL v1

SPL

SPL Set ID 555ac696-e761-4a5a-bed8-945dc64d5be5

Route

TOPICAL

Published

Effective Date 2025-02-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

Water Hydroxypropyl Methylcellulose Melaleuca Alternifolia (tea Tree) Leaf Oil Octoxynol 9 Peg-40 Hydrogenated Castor Oil Glycerin Phenoxyethanol Propylene Glycol Aminomethyl Propanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-27

Description

Active ingredient Lidocaine HCI 2%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Avoid contact with eyes

Indications and Usage

Uses

For temporary relief of pain associated with minor burns.

Dosage and Administration

Directions

Adults and children 2 years of age or older:apply to affected area not more than 3 to 4 times daily

Chilrdren under 2 years old: consult a doctor

Description

Active ingredient Lidocaine HCI 2%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor

if the condition worsens
symptoms persist for more than 7 days
condition clears up and occurs again within a few days

Section 50570-1

Do not use

■ in large quantities, particularly over raw surface or blistered areas

Section 51727-6

Inactive ingredients

glycerin, Hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxyol 9, PEG-40 hydrogenated castor oil, Phenoxyethanol, Polyethylene Glycol, Aminomethyl Propanol, Water

Section 51945-4

Section 55105-1

Purpose

External Analgesic

Section 55106-9

Active ingredient

Lidocaine HCI 2%

Structured Label Content

Indications and Usage (34067-9)

Uses

For temporary relief of pain associated with minor burns.

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age or older:apply to affected area not more than 3 to 4 times daily

Chilrdren under 2 years old: consult a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only.

Avoid contact with eyes

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor

if the condition worsens
symptoms persist for more than 7 days
condition clears up and occurs again within a few days

Section 50570-1 (50570-1)

Do not use

■ in large quantities, particularly over raw surface or blistered areas

Section 51727-6 (51727-6)

Inactive ingredients

glycerin, Hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxyol 9, PEG-40 hydrogenated castor oil, Phenoxyethanol, Polyethylene Glycol, Aminomethyl Propanol, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

External Analgesic

Section 55106-9 (55106-9)

Active ingredient

Lidocaine HCI 2%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For temporary relief of pain associated with minor burns.", "34068-7": "Directions Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily Chilrdren under 2 years old: consult a doctor", "34071-1": "Warnings For external use only . Avoid contact with eyes", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask a doctor if the condition worsens symptoms persist for more than 7 days condition clears up and occurs again within a few days", "50570-1": "Do not use ■ in large quantities, particularly over raw surface or blistered areas", "51727-6": "Inactive ingredients glycerin, Hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxyol 9, PEG-40 hydrogenated castor oil, Phenoxyethanol, Polyethylene Glycol, Aminomethyl Propanol, Water", "55105-1": "Purpose External Analgesic", "55106-9": "Active ingredient Lidocaine HCI 2%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:38.953760 · Updated: 2026-03-14T23:07:47.363489