43473-069 Jj Care Burn Gel

SPL v1

SPL

SPL Set ID d69ebc53-8552-449a-a973-f211328a3d3e

Route

TOPICAL

Published

Effective Date 2025-02-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

Water Aloe Vera Leaf Carbomer 934 Menthol Ethylhexylglycerin Maltodextrin Phenoxyethanol Propylene Glycol Aminomethyl Propanol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-19

Description

Active ingredient Lidocaine HCI 2%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

Temporary pain relief for minor burns.

Dosage and Administration

Directions

Adults and children 2 years of age or older

■ Apply to affected area not more than 4 times daily

Chilrdren under 2 years old

■ Do not use, consult a doctor

Description

Active ingredient Lidocaine HCI 2%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctorif the condition worsens or persists for more than 7 days or clears up and occurs again

Section 50570-1

Do not use

■ in large quantities, particularly over raw or blistered areas

■ near eyes, if this happens rinse thoroughly with water

Section 51727-6

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Phenoxyethanol, Polyethylene Glycol, Tocopheryl Acetate, Water.

Section 51945-4

Section 55105-1

Purpose

Topical Pain Relief

Section 55106-9

Active ingredient

Lidocaine HCI 2%

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary pain relief for minor burns.

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age or older

■ Apply to affected area not more than 4 times daily

Chilrdren under 2 years old

■ Do not use, consult a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctorif the condition worsens or persists for more than 7 days or clears up and occurs again

Section 50570-1 (50570-1)

Do not use

■ in large quantities, particularly over raw or blistered areas

■ near eyes, if this happens rinse thoroughly with water

Section 51727-6 (51727-6)

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Phenoxyethanol, Polyethylene Glycol, Tocopheryl Acetate, Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical Pain Relief

Section 55106-9 (55106-9)

Active ingredient

Lidocaine HCI 2%

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "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": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYL PROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Temporary pain relief for minor burns.", "34068-7": "Directions Adults and children 2 years of age or older ■ Apply to affected area not more than 4 times daily Chilrdren under 2 years old ■ Do not use, consult a doctor", "34071-1": "Warnings For external use only .", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask a doctor if the condition worsens or persists for more than 7 days or clears up and occurs again", "50570-1": "Do not use ■ in large quantities, particularly over raw or blistered areas ■ near eyes, if this happens rinse thoroughly with water", "51727-6": "Inactive ingredients Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Phenoxyethanol, Polyethylene Glycol, Tocopheryl Acetate, Water.", "55105-1": "Purpose Topical Pain Relief", "55106-9": "Active ingredient Lidocaine HCI 2%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:35.308716 · Updated: 2026-03-14T23:07:36.685051