Analgesic - Welly Health PBC

Manufacturer: Welly Health PBC
Effective date: 2019-02-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:02:10

Label at a glance#

ProductAnalgesic

Active ingredientlidocaine hydrochloride

Label structure7 sections

Indications and uses

Temporary pain relief for minor burns

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine

HCl 2.0%

Purpose

OTC - PURPOSE SECTION

Topical

pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief for minor burns

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

External use only. Keep out of reach of children.

Do not use

OTC - DO NOT USE SECTION

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

Stop use, ask a doctor

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Principal Display Panel - Welly Health Burn Gel Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Welly™

Burn Gel

0.9/ 1/32 OZ

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72663-500-04	2022-01-28	C162847	48780-1	d6a99b39-6a4b-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72663-500-04	Analgesic	0.9 mL in 1 POUCH	GEL	0.9		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72663-500	ANALGESIC (LIDOCAINE HYDROCHLORIDE) GEL [WELLY HEALTH PBC]	1	Legacy NDC, 1 package rows	20190225_cce75e29-4922-47f7-a5c6-49823a1873d1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Analgesic
lidocaine hydrochloride
lidocaine
Lidocaine Hydrochloride Anhydrous
aloe vera leaf
carboxypolymethylene
diazolidinyl urea
menthol, unspecified form
propylene glycol
water
trolamine
.alpha.-tocopherol, d-

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72663-500	72663-500-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
lidocaine hydrochloride	V13007Z41A	ACTIR
aloe vera leaf	ZY81Z83H0X	IACT
carboxypolymethylene	0A5MM307FC	IACT
diazolidinyl urea	H5RIZ3MPW4	IACT
menthol, unspecified form	L7T10EIP3A	IACT
propylene glycol	6DC9Q167V3	IACT
water	059QF0KO0R	IACT
trolamine	9O3K93S3TK	IACT
.alpha.-tocopherol, d-	N9PR3490H9	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
13196379-9bda-409e-b7d9-387175599c46			cce75e29-4922-47f7-a5c6-49823a1873d1	2019-02-25	Warnings	Exact identifier spl id: 13196379-9bda-409e-b7d9-387175599c46 spl set id: cce75e29-4922-47f7-a5c6-49823a1873d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.