FDA.reportPublic FDA data

FORMULA 4 PAIN

Manufacturer
Lifequest Creations LLC
Effective date
2023-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:28

Label at a glance#

ProductFORMULA 4 PAIN
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL, UNSPECIFIED FORM
Label structure7 sections

Indications and uses

Fast Pain Relief

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                Purpose

Lidocaine HCl 4%                  Topical Anesthetic

Menthol 1%                          Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Fast Pain Relief

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. NOT INTENDED FOR INGESTION DONT USE ONLARGE AREAS OF THE BODY OR ON CUT, IRRITATED OR SWOLLEN SKIN. Use only as directed, avoid contact with eyes and mucus membranes If pregnant or breast-feeding, ask a health care professional before use. If swallowed, get medical help

Direction

DOSAGE & ADMINISTRATION SECTION

Apply topically to area. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Arnica, EMU OIL, MCT OIL, Hemp seed oil, Glyceryl stearate, Cetearyl Alcohol, Copaiba, Tea Tree, Basil, Rosemary, Rose, Lavender, Ginger, Capsicum, Bergamot

Other information

SPL UNCLASSIFIED SECTION

Great for : Sore muscles, aching joints, gout flare-ups and body pain and other sports related pain.

Menthol crystals gives instant cooling and pain releif. Physician formulated (roll-on-blend) glides on is non-sticky, and absorbs quickly.

Arnica reduces bruising and swelling. Lidocaine helps alleviate stiffness, inflammation, joint pain, muscle soreness and more. Hemp seed oil

allows ingredients to cross and absorb into the skin. With its healing properties, Emu oil reduces fibrosis from skin damage caused by radiation

therapy.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58292-005-012025-01-30C16284748780-12cef2736-98ac-d83d-e063-dadaa90ab31f361c19ab-a7ad-4bce-a8aa-1f4dbfd28e76

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58292-005-01FORMULA 4 PAIN113 g in 1 JARCREAM1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58292-005FORMULA 4 PAIN (LIDOCAINE HCL, MENTHOL) CREAM [LIFEQUEST CREATIONS LLC]11 package rows20230706_361c19ab-a7ad-4bce-a8aa-1f4dbfd28e76.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58292-00558292-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
OLIVE OIL6UYK2W1W1EIACT
SHEA BUTTERK49155WL9YIACT
MANGOI629I3NR86IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PALMAROSA OIL0J3G3O53STIACT
TEA TREE OILVIF565UC2GIACT
EUCALYPTUS OIL2R04ONI662IACT
CAMPHOR (NATURAL)N20HL7Q941IACT
LAVENDER OILZBP1YXW0H8IACT
GINGER OILSAS9Z1SVUKIACT
CAPSICUM OLEORESINUW86K581WYIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ARNICA MONTANA WHOLEO80TY208ZWIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
ff9730da-7762-1902-e053-6394a90a015d361c19ab-a7ad-4bce-a8aa-1f4dbfd28e762023-07-03WarningsExact identifier
spl id: ff9730da-7762-1902-e053-6394a90a015d
spl set id: 361c19ab-a7ad-4bce-a8aa-1f4dbfd28e76

Reported adverse events (FAERS/openFDA)#

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