FDA.reportPublic FDA data

Truu Balance Pain Relief

Manufacturer
Philia Group LLC | A.I.G. Technologies, Inc.
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:51

Label at a glance#

ProductTruu Balance Pain Relief
Active ingredientLidocaine Hydrochloride, MENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

For temporary relief of pain, burning, or itching where applied locally

Dosage and administration

Apply in a circular motion for 30 to 60 seconds For adults and children two-years and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Storage and handling

Protect this product from excessive heat and direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Lidocaine 4% HCl w/wExternal Analgesic
Menthol 1% w/wExternal Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain, burning, or itching where applied locally

Warnings

WARNINGS SECTION

For eternal use only

Avoid contact with eyes

OTC - DO NOT USE SECTION

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

Stop use and ask 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

  • If product is swallowed get medical help or contact a Poison Control Center right away.
  • This product is not intended to diagnose, treat, cure or prevent any disease

Directions

DOSAGE & ADMINISTRATION SECTION

Apply in a circular motion for 30 to 60 seconds

For adults and children two-years and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine, Full Spectrum Hemp Extract. (Aerial Parts)

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sunlight

Questions or Comments

OTC - QUESTIONS SECTION

FDA Registered: NDC No. _____-___-__

SPL UNCLASSIFIED SECTION

Distributed by Philia Group LLC
Address: 4 Flanders Drive, Pine Brook, NJ 07058

PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Truu
Balance

Pain Relief Cream
Organic Full Spectrum CBD
With lidocaine

THIRD PARTY
LAB TESTED

1000mg CBD
4oz | 113g

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PRINCIPAL DISPLAY PANEL - 113 g Bottle Label
PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73596-100-012021-07-23C16284748780-1c7ccaba7-1830-fd44-e053-dadaa90aa01bTruu Balance Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73596-100-01Truu Balance Pain Relief113 g in 1 BOTTLECREAM1131
73596-100-01Truu Balance Pain Relief1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73596-100TRUU BALANCE PAIN RELIEF (LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM) CREAM [PHILIA GROUP LLC]1Legacy NDC, 2 package rows20200817_62290685-c67e-4aa4-8a95-c17b49886d36.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73596-10073596-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lidocaine HydrochlorideV13007Z41AACTIR
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
EMU OIL344821WD61IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LAURETH-7Z95S6G8201IACT
TEA TREE OILVIF565UC2GIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT

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
64ce807f-6f3f-4558-b30c-1b3a63d8282562290685-c67e-4aa4-8a95-c17b49886d362020-08-13WarningsExact identifier
spl id: 64ce807f-6f3f-4558-b30c-1b3a63d82825
spl set id: 62290685-c67e-4aa4-8a95-c17b49886d36

Reported adverse events (FAERS/openFDA)#

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