NDC 72037-136 Acuplus Advanced Therapy For Pain And Recovery

Menthol

NDC Product Code 72037-136

NDC Code: 72037-136

Proprietary Name: Acuplus Advanced Therapy For Pain And Recovery What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 72037 - Innovations For Wellness, Llc
    • 72037-136 - Acuplus Advanced Therapy For Pain And Recovery

NDC 72037-136-03

Package Description: 89 mL in 1 TUBE

NDC Product Information

Acuplus Advanced Therapy For Pain And Recovery with NDC 72037-136 is a a human over the counter drug product labeled by Innovations For Wellness, Llc. The generic name of Acuplus Advanced Therapy For Pain And Recovery is menthol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Innovations For Wellness, Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Acuplus Advanced Therapy For Pain And Recovery Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 35 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • LICORICE (UNII: 61ZBX54883)
  • ILEX PARAGUARIENSIS WHOLE (UNII: QJB02841ZY)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Innovations For Wellness, Llc
Labeler Code: 72037
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Acuplus Advanced Therapy For Pain And Recovery Product Label Images

Acuplus Advanced Therapy For Pain And Recovery Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

​Active Ingredient:

Menthol 3.50%

​Purpose

Topical Analgesic

​Uses:

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

​Warnings:

Use only as directed.

Keep Out Of Reach Of Children

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

When Using This Product:

Avoid contact with the eyes or mucous membranes.

Do Not Apply

  • 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 developsDo not bandageDo not use with heating pad or deviceWash hands after use with cool water.

Stop Use And Ask Doctor If:

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

​Directions:

​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:

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.

* Please review the disclaimer below.

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