FDA.reportPublic FDA data

LIDOSOLVE PAIN RELIEF SPRAY

Manufacturer
HENNIKA HEALTH, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:03

Label at a glance#

ProductLIDOSOLVE PAIN RELIEF
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain.

Dosage and administration

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 of age: consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4.00%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain.

Warnings:

WARNINGS SECTION

not intended for ingestion. For external use only

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, Particularly over raw surfaces, or blistered areas.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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 of age: consult a doctor.

Other information:

SPL UNCLASSIFIED SECTION

  • Store at 20-25°C (68-77°F) and protect from moisture.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

ALoe Barbadensis Leaf (Aloe Vera Gel) JUice, Aqua (Deionized Water), Calendula Officinalis Extract, Chamomilla Matricaria (Chamomile) Extract,Cyanocobalimin (Vitamin B 12), Ethylhexylglycerin, Ethyl Vanillin, Glycerin, Phenoxyethanol, Polysorbate-20, Pyridoxine HCL (Vitamib B6), SD-Alcohol 40B, Sodium Metabisulfite, Tetrasodium EDTA, Zemea (Corn) Propanediol

Questions?

OTC - QUESTIONS SECTION

1-800-272-1875 / www.hennikahealth .com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045432lidocaine HCl 4 % Topical SprayPSN2
1045432lidocaine hydrochloride 40 MG/ML Topical SpraySCD2
1045432lidocaine HCl 4 % Topical SpraySY2
1045432lidocaine HCl 4 % Topical Spray GelSY2

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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
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
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
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
83646-420-00LIDOSOLVE PAIN RELIEF170 g in 1 BOTTLE, SPRAYLIQUID1702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83646-420LIDOSOLVE PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) LIQUID [HENNIKA HEALTH, LLC]2Current NDC, 1 package rows20231112_3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83646-42083646-420-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
CYANOCOBALAMINP6YC3EG204IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ETHYL VANILLINYC9ST449YJIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
SODIUM METABISULFITE4VON5FNS3CIACT
EDETATE SODIUMMP1J8420LUIACT
CORN0N8672707OIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
LIDOSOLVE PAIN RELIEFLIDOCAINE HYDROCHLORIDEHENNIKA HEALTH, LLC3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e22023-11-11WarningsExact identifier
ndc (package): 83646-420-00
ndc (product): 83646-420
ndc11 (package): 83646042000
spl id: 09e3474c-57c6-44f0-e063-6294a90a8568
spl set id: 3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2

Reported adverse events (FAERS/openFDA)#

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