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

  • Category: HUMAN OTC DRUG LABEL

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

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  • ACTIVE INGREDIENTS

    MENTHOL - 10%

    METHYL SALICYLATE - 30%

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  • PURPOSE

    TOPICAL ANALGESIC

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  • USES

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

    • SIMPLE BACKACHE
    • ARTHRITIS
    • STRAINS
    • BRUISES
    • SPRAINS
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  • 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
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  • 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.

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  • 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
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  • 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

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  • QUESTIONS?

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

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  • INGREDIENTS AND APPEARANCE
    ART OF SPORT PAIN RELIEVING  ULTRA STRENGTH
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72698-201
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72698-201-11 89 mL in 1 TUBE; Type 0: Not a Combination Product 01/08/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/08/2019
    Labeler - AOS GROUP INC., THE (093257738)
    Establishment
    Name Address ID/FEI Business Operations
    Health Specialty 794053863 manufacture(72698-201)
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