0.5% lidocaine burn relief gel

0.5% lidocaine burn relief gel
SPL v1
SPL
SPL Set ID 0a1aeff0-bade-457b-a0ac-099d646c0b2e
Route
topical
Published
Effective Date 2026-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
aloe vera leaf juice carbomer homopolymer, unspecified type edetate disodium ethylhexylglycerin fd&c blue no. 1 fd&c yellow no. 5 glycerin menthol, unspecified form maltodextrin propanediol polysorbate 20 phenoxyethanol sodium hydroxide alcohol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-19

Purpose

External analgesic

Description

Lidocaine HCl 0.5%


Medication Information

Warnings

For external use only

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

When using this product avoid contact with the eyes

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

Uses

for the temporary relief of pain and itching associated with • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations

Purpose

External analgesic

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor

Other Information

Store a room temperature • Protect from direct sunlight.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Disodium EDTA, Ethylhexylglycerin, FD&C Blue NO.1, FD&C Yellow NO.5, Glycerin, Menthol, Maltodextrin, Propanediol, Polysorbate 20, Phenoxyethanol, Sodium Hydroxide, SD Alcohol, Water.

Description

Lidocaine HCl 0.5%

Section 42229-5

✓ Soothes & Cools Minor Burns

✓ Menthol Formula for Fast Pain Relief

✓ Helps Prevent Infection

PAIN RELIEVING GEL  WITH ALOE

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road, Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Section 50565-1

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

Packaging

Drug Facts

Active Ingredient

Lidocaine HCl 0.5%


Structured Label Content

Warnings

For external use only

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

When using this product avoid contact with the eyes

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

Uses

for the temporary relief of pain and itching associated with • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations

Purpose

External analgesic

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor

Other Information (Other information)

Store a room temperature • Protect from direct sunlight.

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Carbomer, Disodium EDTA, Ethylhexylglycerin, FD&C Blue NO.1, FD&C Yellow NO.5, Glycerin, Menthol, Maltodextrin, Propanediol, Polysorbate 20, Phenoxyethanol, Sodium Hydroxide, SD Alcohol, Water.

Section 42229-5 (42229-5)

✓ Soothes & Cools Minor Burns

✓ Menthol Formula for Fast Pain Relief

✓ Helps Prevent Infection

PAIN RELIEVING GEL  WITH ALOE

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road, Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Section 50565-1 (50565-1)

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

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Lidocaine HCl 0.5%


Advanced Ingredient Data


Raw Label Data

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