FDA.reportPublic FDA data

AcuPlus Advanced Therapy for Pain and Recovery

Manufacturer
INNOVATIONS FOR WELLNESS, LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:01

Label at a glance#

ProductAcuPlus Advanced Therapy for Pain and Recovery
Active ingredientMENTHOL
Label structure6 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles & Joints associated with arthritis, simple backache, strains, bruises & sprains.

Dosage and administration

​Adults and children 2 years of age and older: ​Apply to affected area not more than three to four times daily.  ​Children under 2 years of age: ​consult a physician.  Store at room temperature.

Label contents#

Full prescribing information#

​Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 3.50%

​Purpose

OTC - PURPOSE SECTION

Topical Analgesic

​Uses:

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles & Joints associated with arthritis, simple backache, strains, bruises & sprains.

​Warnings:

WARNINGS SECTION

Use only as directed.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

When using this product:

OTC - WHEN USING SECTION

Avoid contact with the eyes or mucous membranes.

Do not apply

OTC - DO NOT USE SECTION

  • to wounds or damaged skin.
  • Do not use with other ointments, creams, sprays or liniments.
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Do not use with heating pad or device
  • Wash hands after use with cool water.

Stop use and ask doctor if:

OTC - STOP USE SECTION

Condition worsens, or if symptoms persist for more than 7 days.

​Directions:

DOSAGE & ADMINISTRATION SECTION

​Adults and children 2 years of age and older: ​Apply to affected area not more than three to four times daily.  ​Children under 2 years of age: ​consult a physician.  Store at room temperature.

​Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Cetyl Myristoleate, Ethylhexylglycerin, Glucosamine Sulfate, Glycyrrhiza Glabra (licorice) Root Extract, Ilex Paraguayensis (Yerba Mate') Extract, Isopropyl Alcohol, Magnesium Sulfate, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Pyridoxine HCl (Vitamin B6), Salix Alba (Willow) Bark Extract, Tetrasodium EDTA, Tocophyeryl Acetate (Vitamin E), Triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1089766menthol 3.5 % Topical SolutionPSN2
1089766menthol 35 MG/ML Topical SolutionSCD2
1089766menthol 3.5 % Topical SolutionSY2

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72037-136-03AcuPlus Advanced Therapy for Pain and Recovery89 mL in 1 TUBESOLUTION892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72037-136ACUPLUS ADVANCED THERAPY FOR PAIN AND RECOVERY (MENTHOL) SOLUTION [INNOVATIONS FOR WELLNESS, LLC]2Current NDC, Legacy NDC, 1 package rows20231106_840cfd15-4ea1-49bf-8c4f-86c12461d860.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72037-13672037-136-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETYL MYRISTOLEATE87P8K33Q5XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
LICORICE61ZBX54883IACT
ILEX PARAGUARIENSIS WHOLEQJB02841ZYIACT
ISOPROPYL ALCOHOLND2M416302IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
TEA TREE OILVIF565UC2GIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
SALIX ALBA BARK205MXS71H7IACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
AcuPlus Advanced Therapy for Pain and RecoveryMENTHOLINNOVATIONS FOR WELLNESS, LLC840cfd15-4ea1-49bf-8c4f-86c12461d8602023-11-05WarningsExact identifier
ndc (package): 72037-136-03
ndc (product): 72037-136
ndc11 (package): 72037013603
spl id: 0974c990-eb0f-73ff-e063-6294a90af414
spl set id: 840cfd15-4ea1-49bf-8c4f-86c12461d860

Reported adverse events (FAERS/openFDA)#

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