burn spray

burn spray
SPL v4
SPL
SPL Set ID e5e524cd-bb22-715f-e053-2995a90ab5d3
Route
topical
Published
Effective Date 2024-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
water glycerin tea tree oil phenoxyethanol propylene glycol octoxynol-9 polyoxyl 40 hydrogenated castor oil sodium hydroxide hypromelloses

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-07-28
Purpose

Topical Pain Relief

Description

Lidocaine HCI 2.0%

Medication Information

Warnings

For External Use Only

Indications and Usage

Temporary pain relief associated with minor burns.

Purpose

Topical Pain Relief

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.
Other Information
  • Store at controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients

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

Description

Lidocaine HCI 2.0%

Section 51945-4

Do Not Use
  • In large quantities, particularly over raw or blistered areas
  • Near eyes, if this happens rinse throughly with water
Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4049

Active Ingredient

Lidocaine HCI 2.0%

Questions Or Comments

Call 1-888-296-9067

Stop Use and Ask A Doctor
  • If the condition worsens or persists for more than 7 days or clears up and returns.
Keep Out of the Reach of Children

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

Structured Label Content

Warnings

For External Use Only

Indications and Usage (34067-9)

Temporary pain relief associated with minor burns.

Purpose

Topical Pain Relief

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.
Other Information (Other information)
  • Store at controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients

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

Section 51945-4 (51945-4)

Do Not Use
  • In large quantities, particularly over raw or blistered areas
  • Near eyes, if this happens rinse throughly with water
Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4049

Active Ingredient

Lidocaine HCI 2.0%

Questions Or Comments (Questions or Comments)

Call 1-888-296-9067

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • If the condition worsens or persists for more than 7 days or clears up and returns.
Keep Out of the Reach of Children (Keep out of the 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: 2026-02-15T12:03:17.209118 · Updated: 2026-03-14T23:03:15.788850