FDA.reportPublic FDA data

EMU THERAPY Cool Menthol Therapy Pain Relief Cream

Manufacturer
ACA MANAGEMENT LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:53

Label at a glance#

ProductEMU THERAPY Cool Menthol Therapy Pain Relief Cream
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

Temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

Dosage and administration

For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol, USP (2.75%)

Purpose:

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

Warnings:

WARNINGS SECTION

  • For external use only.

Do not use

OTC - DO NOT USE SECTION

on wounded, damaged or irritated skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes or mucous membranes, do not bandage tightly.

Stop use and ask a doctor 

OTC - STOP USE SECTION

  • if you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 days or clear up and occur again within a few days. 

If pregnant or Breast-Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Capsaicin, Carbomer, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, FD&C Blue #1; FD&C Yellow #5, Glycerin, Hamamelis Virginiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tanacetum Parthenium (Feverfew) Extract, Tilla Cordata (Linden) Bark Extract, Triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2643471menthol 2.75 % Topical CreamPSN4
2643471menthol 27.5 MG/ML Topical CreamSCD4
2643471menthol 2.75 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83591-416-00EMU THERAPY Cool Menthol Therapy Pain Relief Cream237 mL in 1 JARCREAM2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83591-416EMU THERAPY COOL MENTHOL THERAPY PAIN RELIEF CREAM (MENTHOL) CREAM [ACA MANAGEMENT LLC]4Current NDC, 1 package rows20231106_16894346-3513-41b1-b09f-72d84edcc4ac.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83591-41683591-416-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPSAICINS07O44R1ZMIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CHAMOMILEFGL3685T2XIACT
CORIANDER1OV56052IKIACT
EMU OIL344821WD61IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERINPDC6A3C0OXIACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSIACT
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBIACT
LAMIUM ALBUM WHOLE046Y1357I6IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SALIX ALBA BARK205MXS71H7IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
FEVERFEWZ64FK7P217IACT
TROLAMINE9O3K93S3TKIACT
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
EMU THERAPY Cool Menthol Therapy Pain Relief CreamMENTHOLACA MANAGEMENT LLC16894346-3513-41b1-b09f-72d84edcc4ac2023-11-06WarningsExact identifier
ndc (package): 83591-416-00
ndc (product): 83591-416
ndc11 (package): 83591041600
spl id: 097667a6-8c92-70ba-e063-6294a90a7af0
spl set id: 16894346-3513-41b1-b09f-72d84edcc4ac

Reported adverse events (FAERS/openFDA)#

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