Burn Relief, Lidocaine Hcl 0.5%

Burn Relief, Lidocaine Hcl 0.5%
SPL v3
SPL
SPL Set ID b5e76f0c-0bfe-b13e-e053-2995a90a0861
Route
TOPICAL
Published
Effective Date 2020-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Glycerin Isopropyl Alcohol Menthol Propylene Glycol Edetate Disodium Trolamine Carbomer 940 Polysorbate 80 Diazolidinyl Urea Fd&c Yellow No. 5 Fd&c Blue No. 1 Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-04
Description

Lidocaine HCl 0.5%

Medication Information

Warnings and Precautions

For external use only.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: consult a physician.

Dosage and Administration

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

Description

Lidocaine HCl 0.5%

Section 50565-1

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Water, Glycerin, Isopropyl Alcohol, Aloe Barbadensis Leaf Extract, Menthol, Propylene Glycol, Polysorbate 80, Triethanolamine, Carbomer, Disodium EDTA, Blue 1, Yellow 5, Diazolidinyl Urea.

Section 51945-4

Section 55105-1

External Analgesic.

Section 55106-9

Lidocaine HCl 0.5%

Structured Label Content

Indications and Usage (34067-9)

Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: consult a physician.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Water, Glycerin, Isopropyl Alcohol, Aloe Barbadensis Leaf Extract, Menthol, Propylene Glycol, Polysorbate 80, Triethanolamine, Carbomer, Disodium EDTA, Blue 1, Yellow 5, Diazolidinyl Urea.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

External Analgesic.

Section 55106-9 (55106-9)

Lidocaine HCl 0.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:50.544248 · Updated: 2026-03-14T23:05:54.616139