NDC 67234-043 Proplex Greaseless Muscle Rub

Menthol, Unspecified Form And Methyl Salicylate

NDC Product Code 67234-043

NDC Code: 67234-043

Proprietary Name: Proplex Greaseless Muscle Rub Additional informationCallout TooltipWhat 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 Methyl Salicylate Additional informationCallout TooltipWhat 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
  • 67234 - Natureplex Llc
    • 67234-043 - Proplex Greaseless Muscle Rub

NDC 67234-043-01

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC Product Information

Proplex Greaseless Muscle Rub with NDC 67234-043 is a a human over the counter drug product labeled by Natureplex Llc. The generic name of Proplex Greaseless Muscle Rub is menthol, unspecified form and methyl salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Natureplex 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 Additional informationCallout TooltipWhat 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.


Proplex Greaseless Muscle Rub Active Ingredient(s)

Additional informationCallout TooltipWhat 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 10 mg/g
  • METHYL SALICYLATE 15 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POTASSIUM (UNII: RWP5GA015D)
  • CETYL PHOSPHATE (UNII: VT07D6X67O)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • TROLAMINE (UNII: 9O3K93S3TK)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Natureplex Llc
Labeler Code: 67234
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-18-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Proplex Greaseless Muscle Rub Product Label Images

Proplex Greaseless Muscle Rub 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

Avoid contact with eyes and mucus membranes.

Not for prolonged use.

Active Ingredients

Menthol 10%Methyl salicylate 15%

Purposes

Topical AnalgesicTopical Analgesic

Use

Temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only.

Do Not Use

  • Than otherwise directedon wounds or damaged skina bandage tightly

Stop Use And Ask A Physician If

  • Rash or excessive irritation of the skin developscondition worsens or symptoms persist for more than 7 dayscondition clears up and occurs again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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: 800-222-1222.

Directions

  • Adults and children 2 years of age and older:apply to affected area 3 to 4 times dailyChildren under 2 years of age:consult a physician

Other Information

  • Store at 15 to 30°C (59 to 86°F)close cap tightly after useTamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

Carbomer, cetyl alcohol, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, potassium cetyl phosphate, propylparaben, purified water, stearic acid, stearyl alcohol, triethanolamine

* Please review the disclaimer below.

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