FDA.reportPublic FDA data

Eternal Spirit Beauty Painless Pain Relieving Cream

Manufacturer
Prime Enterprises Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:02

Label at a glance#

ProductEternal Spirit Beauty Painless Pain Relieving Cream
Active ingredientMENTHOL
Label structure8 sections

Dosage and administration

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 a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

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. Provides penetrating pain relief.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

  • Avoid contact with the eyes

OTC - STOP USE SECTION

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

OTC - DO NOT USE SECTION

Do not apply to wounds or damaged skin. Do not bandage tightly.

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.

Directions

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 a doctor.

INACTIVE INGREDIENT SECTION

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Propylene Glycol, Glycerin, Glyceryl Stearate, Acrylamide Sodium Acrylate Copolymer, Arnica Montana Flower Extract, Cetyl Alcohol, PEG-100 Stearate, Mineral Oil, Ethoxydiglycol, Boswellia Serrata Extract, Dimethicone, Butyrospermum Parkii (Shea Butter), Fragrance (Parfum), Diazolidinyl Urea, Methylparaben, Trideceth-6, Disodium EDTA, Propylparaben, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Glycyrrhiza Glabra (Licorice) Root Extract, Dimethyl Sulfone, Choline Bitartrate, Pyridoxine, Glucosamine Sulfate, Camphor, Cetyl Myristoleate, Triethanolamine

Questions or Comments?

OTC - QUESTIONS SECTION

Worldwide Cosmetics, Inc.

Eternal Spirit Beauty Painless Pain Relieving Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416982menthol 1.25 % Topical CreamPSN2
416982menthol 12.5 MG/ML Topical CreamSCD2
416982menthol 1.25 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0223-32024-01-30C16284748780-11030e365-11a1-111a-e063-dadaa90a10e2Eternal Spirit Beauty Painless Pain Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0223-3Eternal Spirit BeautyPainless Pain Relieving Cream118 mL in 1 JARCREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0223ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING CREAM (MENTHOL) CREAM [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200118_2bfa9375-aa3d-312a-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-022358443-0223-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
GLYCERINPDC6A3C0OXIACT
PROPYLPARABENZ8IX2SC1OHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
SHEA BUTTERK49155WL9YIACT
METHYLPARABENA2I8C7HI9TIACT
TEA TREE OILVIF565UC2GIACT
CHOLINE BITARTRATE6K2W7T9V6YIACT
EDETATE DISODIUM7FLD91C86KIACT
MINERAL OILT5L8T28FGPIACT
PYRIDOXINEKV2JZ1BI6ZIACT
TROLAMINE9O3K93S3TKIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUNFLOWER OIL3W1JG795YIIACT
MENTHOLL7T10EIP3AACTIB
DIMETHICONE92RU3N3Y1OIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
TRIDECETH-63T5PCR2H0CIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LICORICE61ZBX54883IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CETYL MYRISTOLEATE87P8K33Q5XIACT

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
9c5964a8-115c-17be-e053-2a95a90a68ce2bfa9375-aa3d-312a-e054-00144ff8d46c2020-01-17WarningsExact identifier
spl id: 9c5964a8-115c-17be-e053-2a95a90a68ce
spl set id: 2bfa9375-aa3d-312a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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