NDC 72698-201 Art Of Sport Pain Relieving Ultra Strength

Menthol, Methyl Salicylate

NDC Product Code 72698-201

NDC Code: 72698-201

Proprietary Name: Art Of Sport Pain Relieving Ultra Strength 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, 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
  • 72698 - Aos Group Inc., The
    • 72698-201 - Art Of Sport Pain Relieving

NDC 72698-201-11

Package Description: 89 mL in 1 TUBE

NDC Product Information

Art Of Sport Pain Relieving Ultra Strength with NDC 72698-201 is a a human over the counter drug product labeled by Aos Group Inc., The. The generic name of Art Of Sport Pain Relieving Ultra Strength is menthol, methyl salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Aos Group Inc., The

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.


Art Of Sport Pain Relieving Ultra Strength 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 10 g/100mL
  • METHYL SALICYLATE 30 g/100mL

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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • CLOVE LEAF OIL (UNII: VCA5491KVF)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • SQUALANE (UNII: GW89575KF9)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Aos Group Inc., The
Labeler Code: 72698
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: 01-08-2019 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.

Art Of Sport Pain Relieving Ultra Strength Product Label Images

Art Of Sport Pain Relieving 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

Active Ingredients

MENTHOL - 10%METHYL SALICYLATE - 30%

Purpose

TOPICAL ANALGESIC

Uses

  • TEMPORARILY RELIEVES THE MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH:SIMPLE BACKACHEARTHRITISSTRAINSBRUISESSPRAINS

Warnings

  • For external use onlyDo not use:on wounds or damaged skinwith a heating padon a child under 12 years of age unless directed by a doctorAsk a doctor before use if you have skin irritation or rednessWhen using this product: do not bandage tightlyavoid contact with eyes or mucous membranesStop use and ask a doctor if:excessive skin irritation occurscondition worsens or symptoms persist for more than 7 dayssymptoms clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Use only as directedadults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 12 years of age: ask a doctor

Inactive Ingredients

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, ARNICA MONTANA FLOWER EXTRACT, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CETEARETH-20, CETEARYL ALCOHOL, DIMETHICONE, ETHYLHEXYLGLYCERIN, EUCALYPTUS GLOBULUS LEAF OIL, EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL, GLYCERIN, GLYCERYL STEARATED, HEXYLENE GLYCOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PEG-100 STEARATE, PHENOXYETHANOL, POLYSORBATE 60, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, SORBITAN ISOSTEARATE, SQUALANE, STEARIC ACID, TETRASODIUM GLUTAMATE DIACETATE, WATER, XANTHAN GUM

Questions?

Call 1-503-610-4055       help@artofsport.com

* Please review the disclaimer below.

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