43473-070 ligthning products burn spray

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

Active Ingredient

Active ingredient

Lidocaine HCI         2%

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Avoid contact with eyes

Active Ingredient (55106-9)

Active ingredient

Lidocaine HCI         2%

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)