FDA.reportPublic FDA data

NeuroComfort Pain Relief Gel Extra Strength

Manufacturer
Harmony Products LLC | Steuart Custom Manufacturing
Effective date
2019-06-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:19:29

Label at a glance#

ProductNeuroComfort Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure4 sections

Label contents#

Full prescribing information#

For NDC 73096-002

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label for NDC 73096-002 For 73096-002-01For 73096-002-01

OTC - ACTIVE INGREDIENT SECTION

Natural Menthol USP 2%...................................................................................................Topical Analgesic Active Ing. 500Active Ing. 500

WARNINGS SECTION

Warnings For external use only Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient on open wounds, damaged irritated skin with a heating pad or TENS device after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes Other information store in a cool place away from direct sunlight store with lid closed tightly If pregnant or breast feeding, ask a health professional before use.

Warnings - gel 500Warnings - gel 500

OTC - PURPOSE SECTION

Active ingredient Purpose

Natural Menthol USP 2%.................................................................................................. Topical Analgesic

PurposePurpose

For NDC 73096-003

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label for NDC 73096-00373096-00373096-003

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Natural Menthol USP 2.5%................................................................................................Topical Analgesic

ActiveActive

WARNINGS SECTION

Warnings For external use only Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient on open wounds, damaged irritated skin with a heating pad or TENS device after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes Other information store in a cool place away from direct sunlight store with lid closed tightly If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

WarningsWarnings

INDICATIONS & USAGE SECTION

Uses: For the temporary relief of minor aches and pains

arthritis simple backache strains bruises sprains

UsesUses

OTC - PURPOSE SECTION

Active ingredient Purpose

Natural Menthol USP 2.5%................................................................................................ Topical Analgesic

PurposePurpose

For NDC 73096-001

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For NDC 73096-00173096-00173096-001

OTC - ACTIVE INGREDIENT SECTION

ACtiveACtive

Active ingredient Purpose

Natural Menthol USP 2%...................................................................................................Topical Analgesic

WARNINGS SECTION

WarningsWarnings

Warnings For external use only Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient on open wounds, damaged irritated skin with a heating pad or TENS device after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes Other information store in a cool place away from direct sunlight store with lid closed tightly If pregnant or breast feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Directions

Adults and children 12 years of age and over:

shake well apply to affected area not more than 4 times daily massage painful area until

absorbed into skin wash hands after each use with cold water

Children under 12 years of age: consult a doctor

INDICATIONS & USAGE SECTION

UsUs

OTC - PURPOSE SECTION

PurposePurpose

Active ingredient Purpose

Natural Menthol USP 2%................................................................................................... Topical Analgesic

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
73096-00173096-001-01
73096-00273096-002-01
73096-00373096-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
HEMPTD1MUT01Q7IACT
DIMETHICONE 1000MCU2324216IACT
EUCALYPTUS OIL2R04ONI662IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
SUNFLOWER OIL3W1JG795YIIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
HEMPTD1MUT01Q7IACT
DIMETHICONE 1000MCU2324216IACT
EUCALYPTUS OIL2R04ONI662IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
SUNFLOWER OIL3W1JG795YIIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
HEMPTD1MUT01Q7IACT
DIMETHICONE 1000MCU2324216IACT
EUCALYPTUS OIL2R04ONI662IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
SUNFLOWER OIL3W1JG795YIIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
WATER059QF0KO0RIACT

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
8decac85-44b7-90d3-e053-2995a90aa63c8c53a0bf-2b4b-9337-e053-2995a90a92142019-07-17WarningsExact identifier
spl set id: 8c53a0bf-2b4b-9337-e053-2995a90a9214

Reported adverse events (FAERS/openFDA)#

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