PAIN RELIEF CREAM EXTRA STRENGTH (METHYL SALICYLATE, MENTHOL, CAMPHOR, CAPSAICIN CREAM) CREAM [EVERYDAY MEDICAL LLC]

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PAIN RELIEF CREAM EXTRA STRENGTH (METHYL SALICYLATE, MENTHOL, CAMPHOR, CAPSAICIN CREAM) CREAM [EVERYDAY MEDICAL LLC]
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NDC 72982-1901-1
Set ID 86091483-20a0-5da8-e053-2a91aa0a6f45
Category HUMAN OTC DRUG LABEL
Packager Everyday Medical LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Methyl Salicylate 20% Topical Analgesic

    Menthol 5% Topical Analgesic

    Camphor 4% Topical Analgesic

    Capsaicin.1% Topical Analgesic

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

    temporarily relieves minor pain associated with

    • arthritis
    • simple backache
    • muscle strains
    • bruises
    • sprains
    • cramps
  • WARNINGS

    Warnings

    For external use only

    When using this product: Use only as directed

    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • if severe burning sensation occurs, discontinue use immediately

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
  • 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

    • 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 the age of 12 years of age consult a doctor
  • INACTIVE INGREDIENT

    • Comfrey extract
    • Arnica extract
    • Boswellia serrata extract
    • Emu oil
    • Linseed oil
    • Curcumin
    • Vitamin E acetate oil
    • Cetomacrogol 1000
    • Ceto steryl alcohol
    • Carbopol 2020
    • Light liquid parafin
    • White soft paraffin
    • BHA
    • BHT
    • Glyceryl mono stearate
    • Sodium meta bisulphate
    • Simethicone
    • Purified water
  • PRINCIPAL DISPLAY PANEL

    PRC Front

    PRC Side

    PRC Back

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM EXTRA STRENGTH 
    methyl salicylate, menthol, camphor, capsaicin cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72982-1901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.01 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LINSEED OIL (UNII: 84XB4DV00W)  
    WATER (UNII: 059QF0KO0R)  
    CURCUMIN (UNII: IT942ZTH98)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COMFREY (UNII: D05HXK6R3G)  
    EMU OIL (UNII: 344821WD61)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72982-1901-1141 g in 1 CONTAINER; Type 0: Not a Combination Product04/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/08/2019
    Labeler - Everyday Medical LLC (117001767)
    Registrant - Everyday Medical LLC (117001767)
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