FDA.reportPublic FDA data

Ease Your Pain

Manufacturer
Proximity Capital Partners LLC dba Asutra | BioLyte Laboratories, LLC
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:21

Label at a glance#

ProductEase Your Pain
Active ingredientMENTHOL
Label structure9 sections

Storage and handling

Store in a cool, dry place. Avoid direct sunlight. Tamper-evident for your protection. Use only if safety seal is intact. Keep away from excessive heat or flame.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 4%

OTC - PURPOSE SECTION

Menthol USP 4% ........................... Topical Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

WARNINGS SECTION

Use only as directed.

For external use only.Keep away from excessive heat or flame.

OTC - WHEN USING SECTION

When using this product:

  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments

OTC - STOP USE SECTION

Stop use and ask doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days, or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding:Ask a health professional before using.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

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 physician.

STORAGE AND HANDLING SECTION

  • Store in a cool, dry place.
  • Avoid direct sunlight.
  • Tamper-evident for your protection. Use only if safety seal is intact.
  • Keep away from excessive heat or flame.

INACTIVE INGREDIENT SECTION

Purified Water, Ethyl Alcohol, Dimethyl Sulfone (MSM), Arnica Montana, Calendula Officinalis Flower Extract, Methyl Glucose Dioleate, Sodium Hydroxide, Baobab Oil, Carbomer, Citric Acid

OTC - QUESTIONS SECTION

888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

001001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148430menthol 4 % Topical CreamPSN3
1148430menthol 40 MG/ML Topical CreamSCD3
1148430menthol 4 % Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72683-002-01Ease Your Pain1 in 1 CARTONCREAM13
72683-002-01Ease Your Pain85 g in 1 TUBECREAM853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72683-002EASE YOUR PAIN (MENTHOL) CREAM [PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA]3Current NDC, Legacy NDC, 2 package rows20241215_83366ae1-e1d9-2a30-e053-2a91aa0a1cc4.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72683-00272683-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADANSONIA DIGITATA SEED OIL77MKL7AR5IIACT
ARNICA MONTANAO80TY208ZWIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ALCOHOL3K9958V90MIACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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
Ease Your PainMENTHOLProximity Capital Partners LLC dba Asutra83366ae1-e1d9-2a30-e053-2a91aa0a1cc42024-12-12WarningsExact identifier
ndc (package): 72683-002-01
ndc (product): 72683-002
ndc11 (package): 72683000201
spl id: 291938f2-f0b6-b647-e063-6294a90a44d3
spl set id: 83366ae1-e1d9-2a30-e053-2a91aa0a1cc4

Reported adverse events (FAERS/openFDA)#

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