NDC 42508-282 Essentials Herbal Muscle Massage

Capsicum Oleoresin, Racementhol, And Methyl Salicylate

NDC Product Code 42508-282

NDC 42508-282-11

Package Description: 113 g in 1 TUBE

NDC Product Information

Essentials Herbal Muscle Massage with NDC 42508-282 is a a human over the counter drug product labeled by Arbonne International, Llc. The generic name of Essentials Herbal Muscle Massage is capsicum oleoresin, racementhol, and methyl salicylate. The product's dosage form is gel and is administered via topical form.

Labeler Name: Arbonne International, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Essentials Herbal Muscle Massage 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.

  • CAPSICUM OLEORESIN .32 mg/g
  • RACEMENTHOL 50 mg/g
  • METHYL SALICYLATE 100 mg/g

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.

  • CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • 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: Arbonne International, Llc
Labeler Code: 42508
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: 02-22-2012 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: 12-31-2021 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.

Essentials Herbal Muscle Massage Product Label Images

Essentials Herbal Muscle Massage 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

Allergy alert: if prone to allergic reaction from aspirin or salicylate, consult a doctor before using

Distributed byArbonne International, LLC9400 Jeronimo Road, Irvine, CA 92618

Otc - Purpose

Active ingredientsPurposeCapsaicin 0.032%Topical AnalgesicMenthol 5%Topical AnalgesicMethyl salicylate 10%Topical Analgesic

Uses

  • For temporary relief of minor aches and pains of muscles and joints associated with simple back ache, arthritis, strains, bruises and sprains

Warnings

For external use only

When Using This Product

  • Do not get into eyes. If contact occurs, rinse eyes thoroughly with waterdo not apply to wounds or damaged skindo not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsens or symptoms persist for more than 7 days, or clear up and occur 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

Directions

  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: do not use, and consult a doctor

Other Information

Store at 25°C–30°C (77°F–86°F)

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, aminomethyl propanol, anthemis nobilis flower extract, arnica montana flower extract, butylene glycol, calendula officinalis flower extract, disodium EDTA, eucalyptus globulus leaf oil, hamamelis virginiana (witch hazel) extract, lecithin, phenoxyethanol, water.

* Please review the disclaimer below.