Label: NATRALIA CRAMP RELIEF- methyl salicylate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 18, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Methyl Salicylate 10.5%

  • Purpose

    Pain Relieving

  • Uses

    • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
  • Warnings

    • For External Use Only
       
    • Avoid contact with eyes
       
    • Do not apply to wounds or damaged skin
       
    • Do not bandage tightly
       
    • Do not use other than as directed

    • Keep out of reach of children to avoid accidental poisoning
       
    • If swallowed, seek medical help or contact a Poison Control Center right away

    • If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within few days, discontinue use of this product and consult a physician.

    • Do not use if tube seal is broken or appears tampered with.
  • Directions

    • Adults and children 2 years of age and older: apply to affected area not more than 3 - 4 times daily.
    • Children under 2 years of age: consult a physician.
  • Other information

    • Store between 50° – 86°F in a dry place
  • Inactive ingredients

    Benzyl Alcohol, Ethanol, Eucalyptus Globulus Leaf Oil, Hydroxyethyl Acrylate/Sodium Acryloyldimethyltaurate Copolymer (and) Squalane (and) Polysorbate 60, Lavandula Angustifolia (Lavender) Oil, PEG-40 Hydrogenated Castor Oil, Tocopherol, Water.

  • Questions or comments?

    Call Toll Free 1-877-687-2542

    usainfo@natralia.com.au

    www.natralia.com.au/usa

  • PRINCIPAL DISPLAY PANEL - 56g Tube Carton

    natralia™
    NATURALLY AUSTRALIAN

    muscle cramp
    relief gel

    natural alternative

    FAST
    ACTING

    Topical Analgesic

    A natural alternative
    for the temporary
    relief of:

    • Minor Aches
    • Muscle Pain
    • Joint Pain

    Net Wt 2 oz (56g)

    PRINCIPAL DISPLAY PANEL - 56g Tube Carton
  • INGREDIENTS AND APPEARANCE
    NATRALIA CRAMP RELIEF 
    methyl salicylate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-3213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate105 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Alcohol (UNII: 3K9958V90M)  
    Corymbia Citriodora Leaf Oil (UNII: M63U6N96EB)  
    Squalane (UNII: GW89575KF9)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43251-3213-31 in 1 CARTON
    156 g in 1 TUBE
    2NDC:43251-3213-43 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other03/01/2009
    Labeler - Laderma Trading Pty Ltd (758651624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jalco Pharmaceuticals Pty Ltd757701409MANUFACTURE, PACK, LABEL, ANALYSIS
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