FDA.reportPublic FDA data

HealthWise Soothing Lidocaine Pain Relief Gel

Manufacturer
Veridian Healthcare | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:37:25

Label at a glance#

ProductHealthWise Soothing Lidocaine Pain Relief
Active ingredientLIDOCAINE HYDROCHLORIDE ANHYDROUS
Label structure14 sections

Indications and uses

Uses Temporary relief of pain and itching associated with: ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites ■ minor skin irritations

Dosage and administration

Directions Adults and children 2 years of age and older: ■ apply a thin film over affected area not more than 3 to 4 times daily Children under 2 years of age: ■ do not use, ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 0.5%

Purpose

OTC - PURPOSE SECTION

  • Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Uses Temporary relief of pain and itching associated with:

■ minor burns

■ sunburn
■ minor cuts

■ scrapes

■ insect bites

■ minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
Adults and children 2 years of age and older: ■ apply a thin film over affected area not more than 3 to 4 times daily

Children under 2 years of age: ■ do not use, ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store in a cool dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, carbomer, disodium EDTA, ethylhexylglycerin, FD&C blue no.1, FD&C yellow no.5, glycerin, maltodextrin, menthol, phenoxyethanol, polysorbate 20, propanediol, SD alcohol, sodium hydroxide, water

When using this product, do not

OTC - WHEN USING SECTION

When using this product avoid contact with eyes or mucous membranes

Do not use

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, if symptoms last more than 7 days or clear up and reoccur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011849lidocaine HCl 0.5 % Topical GelPSN1
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCD1
1011849lidocaine hydrochloride 0.5 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-986-01HealthWise Soothing Lidocaine Pain Relief1 in 1 BOXGEL11
71101-986-01HealthWise Soothing Lidocaine Pain Relief226 g in 1 BOTTLEGEL2261

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-98671101-986-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER0A5MM307FCIACT
PROPANEDIOL5965N8W85TIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
LEVOMENTHOLBZ1R15MTK7IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSEC2CNF7XFPACTIB
FD&C YELLOW NO. 5I753WB2F1MIACT
POLYSORBATE 207T1F30V5YHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MALTODEXTRIN7CVR7L4A2DIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Soothing Lidocaine Pain ReliefLIDOCAINE HCI 0.5%Veridian Healthcare4a2ec73e-7332-6f13-e063-6294a90a85062026-02-06WarningsExact identifier
ndc (package): 71101-986-01
ndc (product): 71101-986
ndc11 (package): 71101098601
spl id: 4a2ec2d3-f0ca-f306-e063-6394a90afeca
spl set id: 4a2ec73e-7332-6f13-e063-6294a90a8506

Reported adverse events (FAERS/openFDA)#

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