1168 Burn Spray

1168 Burn Spray
SPL v1
SPL
SPL Set ID 1183a4f5-f875-dfb0-e063-6394a90af35f
Route
TOPICAL
Published
Effective Date 2024-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Melaleuca Alternifolia (tea Tree) Leaf Oil Water Octoxynol 9 Polyoxyl 40 Hydrogenated Castor Oil Glycerin Phenoxyethanol Trolamine Hypromellose, Unspecified Propylene Glycol

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-29
Description

Lidocaine Hydrochloride 2%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Lidocaine Hydrochloride 2%

Label

1168 Label

Use(s)

For the temporary relief of pain associated with minor burns

Warnings

For External Use Only

Directions

• Adults and children 12 years of age and older: Spray an even layer of burn spray over cleaned, affected area not more than 3 to 4 times daily.

• Children under 12 years of age: Consult a doctor before use

Do Not Use

• Over large areas of the body, particularly over raw surfaces, or blistered areas

• Near eyes. If contact occurs, rinse thoroughly with water.

Questions?

1-888-Dynarex Monday - Friday, 9AM - 5PM EST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• Store at 20º-25ºC (68º-77°F)

Inactive Ingredients

Glycerin, Hydroxypropyl Methyl Cellulose, Melaleuca Alterniflia (Tea Tree) Leaf Oil, Octoxynol 9, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Triethanolamine

Stop Use and Ask A Doctor If

Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

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

Structured Label Content

Label

1168 Label

Use(s)

For the temporary relief of pain associated with minor burns

Purpose

Topical Analgesic

Warnings

For External Use Only

Directions

• Adults and children 12 years of age and older: Spray an even layer of burn spray over cleaned, affected area not more than 3 to 4 times daily.

• Children under 12 years of age: Consult a doctor before use

Do Not Use (Do not use)

• Over large areas of the body, particularly over raw surfaces, or blistered areas

• Near eyes. If contact occurs, rinse thoroughly with water.

Questions?

1-888-Dynarex Monday - Friday, 9AM - 5PM EST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• Store at 20º-25ºC (68º-77°F)

Inactive Ingredients

Glycerin, Hydroxypropyl Methyl Cellulose, Melaleuca Alterniflia (Tea Tree) Leaf Oil, Octoxynol 9, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Triethanolamine

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.017281 · Updated: 2026-03-14T23:02:33.495898