Burn Relief Spray

Burn Relief Spray
SPL v3
SPL
SPL Set ID bec60c93-5abd-ee04-e053-2a95a90acb61
Route
TOPICAL
Published
Effective Date 2021-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.5 g)
Inactive Ingredients
Propylparaben Methylparaben Propylene Glycol Water Glycerin Aloe Vera Leaf Alcohol Disodium Cocoamphodipropionate Carbomer 940 Edetate Disodium Trolamine Diazolidinyl Urea .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-31
Description

Lidocaine 0.5%

Medication Information

Warnings and Precautions

For external use only. Flammable--Keep away from fire or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

Dosage and Administration

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Description

Lidocaine 0.5%

Section 50565-1

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

Section 51727-6

Water, Alcohol Denat., Propylene Glycol, Glycerin, Aloe Barbadnesis Leaf Extract, Tocopheryl Acetate, Disodium Cocoamphodipropionate, Carbomer, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Propylparaben, Methylparaben, Simethicone.

Section 51945-4

Section 55105-1



External Analgesic

Section 55106-9

Lidocaine 0.5%

Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

Dosage and Administration (34068-7)

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Warnings and Precautions (34071-1)

For external use only. Flammable--Keep away from fire or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, Alcohol Denat., Propylene Glycol, Glycerin, Aloe Barbadnesis Leaf Extract, Tocopheryl Acetate, Disodium Cocoamphodipropionate, Carbomer, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Propylparaben, Methylparaben, Simethicone.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



External Analgesic

Section 55106-9 (55106-9)

Lidocaine 0.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:50.547990 · Updated: 2026-03-14T23:05:54.616139