NDC 73132-001 Green Compass Reduce Topical Pain

Camphor, Menthol, Methyl Salicylate

NDC Product Code 73132-001

NDC Code: 73132-001

Proprietary Name: Green Compass Reduce Topical Pain 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: Camphor, Menthol, Methyl 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

  • 73132 - Green Compass, Inc.
    • 73132-001 - Green Compass Reduce Topical Pain

NDC 73132-001-50

Package Description: 1 BOTTLE in 1 CARTON > 50 mL in 1 BOTTLE

NDC Product Information

Green Compass Reduce Topical Pain with NDC 73132-001 is a a human over the counter drug product labeled by Green Compass, Inc.. The generic name of Green Compass Reduce Topical Pain is camphor, menthol, methyl salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Green Compass, Inc.

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.

Green Compass Reduce Topical Pain 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.

  • CAMPHOR (NATURAL) 3 g/100mL
  • MENTHOL, UNSPECIFIED FORM 10 g/100mL
  • METHYL SALICYLATE 10 g/100mL

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.

  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
  • CINNAMON LEAF OIL (UNII: S92U8SQ71V)
  • EQUISETUM ARVENSE WHOLE (UNII: 73DM367W4P)
  • TURMERIC (UNII: 856YO1Z64F)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HEMP (UNII: TD1MUT01Q7)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ROSEMARY (UNII: IJ67X351P9)
  • STARCH, TAPIOCA (UNII: 24SC3U704I)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • WATER (UNII: 059QF0KO0R)

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: Green Compass, Inc.
Labeler Code: 73132
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: 07-24-2019 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.

Green Compass Reduce Topical Pain Product Label Images

Green Compass Reduce Topical Pain 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

LEARN MORE AT GreenCompassGlobal.comDISTRIBUTED BY:Green Compass, Inc.1121 Military Cutoff Rd., Ste C339Wilmington, NC 28405 USA

Otc - Active Ingredient

Active ingredientsCamphor 3%Menthol 10%Methyl Salicylate 10%

Otc - Purpose

PurposeTopical AnalgesicTopical AnalgesicTopical Analgesic

Indications & Usage

UsesFor temporary relief of minor aches and pains of muscles and joints.

Warnings

WarningsFor external use only.

Otc - Do Not Use

  • Do not useon wounds or damaged skinwith a heating pad

Otc - When Using

  • When using this productavoid contact with the eyesdo not bandage tightly

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms last more than 7 dayscondition clears up and occurs again within a few days

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.

Dosage & Administration

  • Directionsadults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 12 years of age: ask a doctor

Inactive Ingredient

Inactive ingredientsbutyrospermum parkii (shea) butter, caprylhydroxamid acid, caprylic capric triglyceride, CBD hemp extract, cetearyl alcohol, cetearyl glucoside, citric acid, glycerin, glyceryl caprylate, glyceryl stearate citrate, organic aloe barbadensis (aloe vera) leaf juice, organic arnica extract, organic cinnamon leaf essential oil, organic hemp oil, organic horsetail oil, organic rosmarinum officinalis (rosemary) leaf extract, organic tapioca starch modified, sodium ascorbyl phosphate, turmeric extract, water (aqua), xanthan gum.

* Please review the disclaimer below.

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