FDA.reportPublic FDA data

EB301AP PAIN RELIEF

Manufacturer
EMINENCE BIOTECH CORPORATION LIMITED
Effective date
2018-03-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:54:56

Label at a glance#

ProductEB301AP PAIN RELIEF
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Spray sufficient amount onto affected area to cover it completely, and rub until dry. Repeat no more than 3 to 4 times daily. consult a doctor.

Storage and handling

Store at cool place (room temperature) away from heat and light sources.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on ears or nasal cavity
  • if pregnant
  • on wounds or damaged skin
  • otherwise than as directed

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsen
  • symptoms persist for more than 7 days, or symptoms clear up and occur again within a few days

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over

SPL UNCLASSIFIED SECTION

Spray sufficient amount onto affected area to cover it completely, and rub until dry. Repeat no more than 3 to 4 times daily.

Children under 12 years of age

SPL UNCLASSIFIED SECTION

consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at cool place (room temperature) away from heat and light sources.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Animal Fat, Euphorbia Hirta, Euphorbia Thymifolia Whole, Gaultheria Procumbens (Wintergreen) leaf Extract, Glycerin, Water

Questions?

OTC - QUESTIONS SECTION

Call 1-562-207-8624

SPL UNCLASSIFIED SECTION

Distributed by:

EMINENCE BIOTECH CORPORATION LIMITED

3411 SILVERSIDE ROAD, RODNEY BUILDING # 104
WILMINGTON DE19810 NEW CASTLE COUNTY, USA

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EB
Eminence
Biotech

EB301AP

PAIN RELIEVING SPRAY

3.38FL OZ (100mL)

NDC 53304-0301-1

Principal Display Panel - 100 mL Bottle Carton
Principal Display Panel - 100 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1371206menthol 1 % Topical SprayPSN3
1371206menthol 10 MG/ML Topical SpraySCD3
1371206menthol 1 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53304-0301-12023-01-30C16284748780-1f386c649-c8db-0266-e053-dadaa90a7c1aEB301AP PAIN RELIEF
53304-0301-32023-01-30C16284748780-1f386c649-c8db-0266-e053-dadaa90a7c1aEB301AP PAIN RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53304-0301-1EB301AP PAIN RELIEF1 in 1 BOXSPRAY13
53304-0301-1EB301AP PAIN RELIEF100 mL in 1 BOTTLE, SPRAYSPRAY1003
53304-0301-3EB301AP PAIN RELIEF1 in 1 BOXSPRAY13
53304-0301-3EB301AP PAIN RELIEF15 mL in 1 BOTTLE, SPRAYSPRAY153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53304-0301EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]3Legacy NDC, 4 package rows20180321_3a5fe77f-c36a-41c0-ba86-0664b942e144.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
MENTHOLACTIVE MOIETYL7T10EIP3A2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
EUPHORBIA HIRTAINACTIVE INGREDIENTL13YF113GN2
EUPHORBIA THYMIFOLIA WHOLEINACTIVE INGREDIENTD56Y3D2OTL2
GAULTHERIA PROCUMBENS LEAFINACTIVE INGREDIENT2125M16OWN2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
PORK SIDE BACON, CURED FATINACTIVE INGREDIENT6E710H379S2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53304-030153304-0301-1, 53304-0301-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT
EUPHORBIA HIRTAL13YF113GNIACT
PORK SIDE BACON, CURED FAT6E710H379SIACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
GLYCERINPDC6A3C0OXIACT
EUPHORBIA THYMIFOLIA WHOLED56Y3D2OTLIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 134 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates

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
5a7a2a80-df3b-4501-abbe-62a5d062134f3a5fe77f-c36a-41c0-ba86-0664b942e1442018-03-20WarningsExact identifier
spl id: 5a7a2a80-df3b-4501-abbe-62a5d062134f
spl set id: 3a5fe77f-c36a-41c0-ba86-0664b942e144

Reported adverse events (FAERS/openFDA)#

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