Label: ART OF SPORT PAIN RELIEVING ULTRA STRENGTH- menthol, methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 10, 2019

If you are a consumer or patient please visit this version.

  • 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 BACKACHE
    • ARTHRITIS
    • STRAINS
    • BRUISES
    • SPRAINS
  • WARNINGS

    For external use only

    Do not use:

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age unless directed by a doctor

    Ask a doctor before use if you have skin irritation or redness

    When using this product:

    • do not bandage tightly
    • avoid contact with eyes or mucous membranes

    Stop use and ask a doctor if:

    • excessive skin irritation occurs
    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • 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 directed
    • adults 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 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

  • PRINCIPAL DISPLAY PANEL

    AOS ART OF SPORT PAIN RELIEVING CREAM.jpg

  • INGREDIENTS AND APPEARANCE
    ART OF SPORT PAIN RELIEVING  ULTRA STRENGTH
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72698-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72698-201-1189 mL in 1 TUBE; Type 0: Not a Combination Product01/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/08/2019
    Labeler - AOS GROUP INC., THE (093257738)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Specialty794053863manufacture(72698-201)