FDA.reportPublic FDA data

Relief Pain Relieving Cream

Manufacturer
Corganics, LP | JW Nutritional LLC
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:58:03

Label at a glance#

ProductRelief Pain Relieving Cream
Active ingredientMENTHOL
Label structure8 sections

Dosage and administration

Adults and children 2 years old and older: apply a small amount to affected area not more than 3 to 4 times daily. Gently massage until absorbed. Children under 2 years of age: consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Menthol 3%

PURPOSE

OTC - PURPOSE SECTION

Counterirritant

USAGE

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

WARNINGS

WARNINGS SECTION

For external use only. Avoid contact with the eyes. If condition worsens, or if symptons persist for more than 7 days or clear up and occur again after a few days, discontinue use of this product and consult a physician.

Do Not Use

  • on wounds or damaged skin
  • when bandaged tightly or with a heating pad
  • with other topical products

KEEP OUT OF REACH OF CHILDREN

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 immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years old and older: apply a small amount to affected area not more than 3 to 4 times daily.
  • Gently massage until absorbed.
  • Children under 2 years of age: consult a physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Caprylic/Capric Triglycerides, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Sweet Orange) Oil, Cymbopogon Martini (Palmarosa) Oil, Deionized Water, Eucalyptus Globulus Leaf Oil, Glycerine, L-Arginine Monohydrochloride, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint Oil), Methylsulfonylmethane, Phenoxyethanol, Potassium Hydroxide, Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CONTAINER LABELCONTAINER LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442261menthol 3 % Topical CreamPSN7
1442261menthol 30 MG/ML Topical CreamSCD7
1442261menthol 3 % Topical CreamSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58559-002-012026-01-29C16284748780-149896155-da22-586f-e063-e6dba90add90DRUG FACTS
58559-002-022026-01-29C16284748780-149896155-da22-586f-e063-e6dba90add90DRUG FACTS
58559-002-032026-01-29C16284748780-149896155-da22-586f-e063-e6dba90add90DRUG FACTS
58559-002-042026-01-29C16284748780-149896155-da22-586f-e063-e6dba90add90DRUG FACTS
58559-002-052026-01-29C16284748780-149896155-da22-586f-e063-e6dba90add90DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58559-002-01Relief Pain Relieving Cream5 g in 1 BLISTER PACKCREAM57
58559-002-02Relief Pain Relieving Cream82 g in 1 BOTTLE, WITH APPLICATORCREAM827
58559-002-03Relief Pain Relieving Cream115 g in 1 TUBECREAM1157
58559-002-04Relief Pain Relieving Cream450 g in 1 BOTTLE, PUMPCREAM4507
58559-002-05Relief Pain Relieving Cream3600 g in 1 BOTTLE, PUMPCREAM36007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58559-002RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]7Legacy NDC, 5 package rows20231027_b92e7078-cdaa-4c7d-a6e4-1a8e5bb1d5e1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58559-002-01GM - Gram58559-00259a4811c-40f5-48e5-83e4-c3c76b9a2c1212017-03-06

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58559-00258559-002-01, 58559-002-02, 58559-002-03, 58559-002-04, 58559-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALOEV5VD430YW9IACT
BENZYL ALCOHOLLKG8494WBHIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
ORANGE OILAKN3KSD11BIACT
PALMAROSA OIL0J3G3O53STIACT
WATER059QF0KO0RIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
ARGININE94ZLA3W45FIACT
LAVENDER OILZBP1YXW0H8IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
3c595637-ebd2-43db-b40f-1f5ac2dbe234b92e7078-cdaa-4c7d-a6e4-1a8e5bb1d5e12023-10-26WarningsExact identifier
spl id: 3c595637-ebd2-43db-b40f-1f5ac2dbe234
spl set id: b92e7078-cdaa-4c7d-a6e4-1a8e5bb1d5e1

Reported adverse events (FAERS/openFDA)#

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