Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID cce75e29-4922-47f7-a5c6-49823a1873d1

Route

TOPICAL

Published

Effective Date 2019-02-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Inactive Ingredients

Aloe Vera Leaf Carboxypolymethylene Diazolidinyl Urea Menthol, Unspecified Form Propylene Glycol Water Trolamine .alpha.-tocopherol, D-

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2019-02-25

Description

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Medication Information

Purpose

Topical

pain relief

Description

Lidocaine HCl 2.0%

Uses

Temporary pain relief for minor burns

Section 50565-1

External use only. Keep out of reach of children.

Directions

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
children under 2: do not use, ask a doctor

Do Not Use

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

Active Ingredient

Lidocaine

HCl 2.0%

Inactive Ingredients

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Stop Use, Ask A Doctor

if conditions worsen or last more than 7 days or clears up and returns. If ingested contact a Poison Control Center directly

Principal Display Panel Welly Health Burn Gel Pouch Label

Welly™

Burn Gel

0.9/ 1/32 OZ

Structured Label Content

Uses

Temporary pain relief for minor burns

Section 50565-1 (50565-1)

External use only. Keep out of reach of children.

Purpose

Topical

pain relief

Directions

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
children under 2: do not use, ask a doctor

Do Not Use (Do not use)

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

Active Ingredient (Active ingredient)

Lidocaine

HCl 2.0%

Inactive Ingredients (Inactive ingredients)

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Stop Use, Ask A Doctor (Stop use, ask a doctor)

if conditions worsen or last more than 7 days or clears up and returns. If ingested contact a Poison Control Center directly

Principal Display Panel Welly Health Burn Gel Pouch Label (Principal Display Panel - Welly Health Burn Gel Pouch Label)

Welly™

Burn Gel

0.9/ 1/32 OZ

Advanced Ingredient Data

[{"name": "Lidocaine Hydrochloride Anhydrous", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "aloe vera leaf", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "carboxypolymethylene", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "diazolidinyl urea", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "menthol, unspecified form", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "propylene glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "trolamine", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".alpha.-tocopherol, d-", "unii": "N9PR3490H9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary pain relief for minor burns", "50565-1": "External use only. Keep out of reach of children.", "Purpose": "Topical pain relief", "Directions": "adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2: do not use, ask a doctor", "Do not use": "near eyes, if this happens, rinse thoroughly with water in large quantities, particularly over raw or blistered areas", "Active ingredient": "Lidocaine HCl 2.0%", "Inactive ingredients": "aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate Welly Health PBC, Minn., MN 55402 1-833-BE-WELLY", "Stop use, ask a doctor": "if conditions worsen or last more than 7 days or clears up and returns. If ingested contact a Poison Control Center directly", "Principal Display Panel - Welly Health Burn Gel Pouch Label": "Welly™ Burn Gel 0.9/ 1/32 OZ"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:21.420498 · Updated: 2026-03-14T23:01:50.647319