NDC 72581-428 Inmotion Pain Creme Ultra Strength

Menthol, Unspecified Form And Trolamine Salicylate

NDC Product Code 72581-428

NDC Code: 72581-428

Proprietary Name: Inmotion Pain Creme Ultra Strength 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, Unspecified Form And Trolamine Salicylate 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.

NDC Code Structure

  • 72581 - Inmotion Products Llc
    • 72581-428 - Inmotion Pain Creme Ultra Strength

NDC 72581-428-73

Package Description: 1 TUBE in 1 CARTON > 73 mL in 1 TUBE

NDC Product Information

Inmotion Pain Creme Ultra Strength with NDC 72581-428 is a a human over the counter drug product labeled by Inmotion Products Llc. The generic name of Inmotion Pain Creme Ultra Strength is menthol, unspecified form and trolamine salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Inmotion Products Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Inmotion Pain Creme Ultra Strength 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, UNSPECIFIED FORM 40 mg/mL
  • TROLAMINE SALICYLATE 20 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.

  • WATER (UNII: 059QF0KO0R)
  • SESAME OIL (UNII: QX10HYY4QV)
  • CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCERYL LAURATE (UNII: Y98611C087)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALCOHOL (UNII: 3K9958V90M)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ETHYL LAUROYL ARGINATE (UNII: E0K8J7A41B)

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: Inmotion Products Llc
Labeler Code: 72581
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: 05-12-2019 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.

Inmotion Pain Creme Ultra Strength Product Label Images

Inmotion Pain Creme Ultra Strength 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

Other

Drug Facts

Distributed By: InMotion Products LLC 4639 Torrey Circle, M-102, San Diego, Ca 92130

Active Ingredients

Menthol 4%, Trolamine Salicylate 2%

Purpose

Topical Analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:arthritissimple backachemuscle strainssprainsbruisescramps

Warnings

For external use onlyUse only as directed

When To Use This Product

  • Do not bandage tightly or use with a heating padavoid contact with eyes and mucous membranesdo not apply to wounds or damaged, broken or irritated skinif a burning sensation occurs, discontinue use immediatelydo not expose the area treated with product to heat or direct sunlight

Stop Use And Ask A Doctor If

  • Condition worsensredness is presentirritation developssymptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding: ask a health professional

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children over 12 yearsapply generously to affected areamassage painful area until thoroughly absorbed into skinrepeat as necessary up to 3 times daily

Inactive Ingredients

Purified Water, Sesame Oil, Cetylated Fatty Acids (Cetyl Myristyloleate), Glycerin, Organic Hempseed, B-Caryophilene 8%, Boswellia serrata, Lavender Oil, PEG 100 Stearate, Glyceryl Monolaurate, Cetearyl Alchohol, Cetearyl Glucoside, Cyclopentasiloxane, Cetyl Alchohol, Phosphatidylcholine, Glyceryl Stearate, Butyrospermum Parkii (SheaButter), Aloe Barbadensis Leaf Juice, Dimethicone, Ethyl Alchohol, SclerotiumGum, PotassiumSorbate, Ascorbyl Palmitate, Vitamin E Acetate, Ethyl Lauoryl Arginate, Polyaminopropyl Biguanide

* Please review the disclaimer below.

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