Globe First Aid Burn Gel

SPL v3

SPL

SPL Set ID e9d3e9be-1036-fad0-e053-2a95a90a6efe

Route

TOPICAL

Published

Effective Date 2024-07-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

.alpha.-tocopherol Carbomer Homopolymer, Unspecified Type Menthol Water Ethylhexylglycerin Propylene Glycol Aloe Vera Leaf Sodium Hydroxide Maltodextrin Phenoxyethanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-09-27

Description

Lidocaine HCL 2%

Purpose

Topical Pain Relief

Medication Information

Purpose

Topical Pain Relief

Description

Lidocaine HCL 2%

Uses

Temporary pain relief for minor burns. For professional use only.

Section 51945-4

Warnings

For external Use Only

Do not use

in large quantities, particularly over raw or blistered areas
near eyes, if this happens rinse thoroughly with water

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: do not use, consult a doctor

Questions?

Call 1-888-296-9067

Active Ingredient

Lidocaine HCL 2%

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Storage Information

Store at room temperature (do not freeze)
do not use any opened or torn packets

Inactive Ingredients

Aloe barbadensis leaf juice, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Phenoxyethanol, Propylene glycol, purified water, Triethanolamine, Vitamin E acetate

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.

Keep Out of Reach of Children

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

Structured Label Content

Uses

Temporary pain relief for minor burns. For professional use only.

Section 51945-4 (51945-4)

Purpose

Topical Pain Relief

Warnings

For external Use Only

Do not use

in large quantities, particularly over raw or blistered areas
near eyes, if this happens rinse thoroughly with water

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: do not use, consult a doctor

Questions?

Call 1-888-296-9067

Active Ingredient

Lidocaine HCL 2%

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Storage Information

Store at room temperature (do not freeze)
do not use any opened or torn packets

Inactive Ingredients

Aloe barbadensis leaf juice, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Phenoxyethanol, Propylene glycol, purified water, Triethanolamine, Vitamin E acetate

Stop Use and Ask A Doctor If (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.

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

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

Advanced Ingredient Data

[{"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "0.02", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary pain relief for minor burns. For professional use only.", "Purpose": "Topical Pain Relief", "Warnings": "For external Use Only Do not use in large quantities, particularly over raw or blistered areas near eyes, if this happens rinse thoroughly with water", "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: do not use, consult a doctor", "Questions?": "Call 1-888-296-9067", "Active Ingredient": "Lidocaine HCL 2%", "Other Information": "Distributed By: Trifecta Pharmaceuticals USA® 101 NE Third Ave. Ste 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com", "Storage Information": "Store at room temperature (do not freeze) do not use any opened or torn packets", "Inactive Ingredients": "Aloe barbadensis leaf juice, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Phenoxyethanol, Propylene glycol, purified water, Triethanolamine, Vitamin E acetate", "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.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:17.211586 · Updated: 2026-03-14T23:03:15.788850