Burn Spray

Burn Spray
SPL v1
SPL
SPL Set ID c5ff392a-e788-43e0-91ea-5e0f8420586c
Route
TOPICAL
Published
Effective Date 2025-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-15

Description

Active Ingredients: Lidocaine HCL 2%


Medication Information

Warnings and Precautions

Warnings

For external use only

See a doctor immediately or serious burns

Indications and Usage

Uses:

Temporary pain relief of minor burns

Dosage and Administration

Directions:

Adults and children 2 years of age and over:

  • clean the affected area
  • apply to the affected area not more than 3 to 4 times dailys
  • may be covered with a sterile bandage when dry

Children under 2 years of age: ask a doctor

Description

Active Ingredients: Lidocaine HCL 2%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9

Stop use and ask a doctor if

  • condition lasts for more than 7 days
  • condition worsens
  • symptoms clear up and occur again within a few days
Section 50570-1

Do not use

  • in or near the eyes
  • over large portions of the body
  • in large quantities particularly over raw surfaces or blistered areas
  • on serious burns
  • longer than 7 days unless directed by a doctor
  • on animal bites
  • on deep or puncture wounds
Section 51727-6

Inactive Ingredients

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

Section 51945-4
Section 55105-1

Purpose:

Topical Anesthetic

Section 55106-9

Active Ingredients:

Lidocaine HCL 2%

Section 60561-8

store at 68° to 77°F (20-25°C)


Structured Label Content

Indications and Usage (34067-9)

Uses:

Temporary pain relief of minor burns

Dosage and Administration (34068-7)

Directions:

Adults and children 2 years of age and over:

  • clean the affected area
  • apply to the affected area not more than 3 to 4 times dailys
  • may be covered with a sterile bandage when dry

Children under 2 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

See a doctor immediately or serious burns

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition lasts for more than 7 days
  • condition worsens
  • symptoms clear up and occur again within a few days
Section 50570-1 (50570-1)

Do not use

  • in or near the eyes
  • over large portions of the body
  • in large quantities particularly over raw surfaces or blistered areas
  • on serious burns
  • longer than 7 days unless directed by a doctor
  • on animal bites
  • on deep or puncture wounds
Section 51727-6 (51727-6)

Inactive Ingredients

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

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Purpose:

Topical Anesthetic

Section 55106-9 (55106-9)

Active Ingredients:

Lidocaine HCL 2%

Section 60561-8 (60561-8)

store at 68° to 77°F (20-25°C)


Advanced Ingredient Data


Raw Label Data

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