Label: PAIN GOODBYE AQUEOUS PATCH- methyl salicylate patch

  • 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 October 10, 2013

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

  • ACTIVE INGREDIENTS

    Methyl Salicylate   50 mg

    L-Methenol            80 mg

  • PURPOSE

    Methyl Salucylate   External Analgesic

    L-Methenol             External Analgesic

  • USES

    Uses for the temporary relief of minor aches, and points of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • WARNINGS

    For External Use Only. Do not use on wounds, on infected or damaged skin.

  • Stop use and ask a doctor if

    Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.

  • Stop use and ask a doctor if

    Condition worsens.

    Symptom clears up and occurs again within a few days.

    Symptom persists for more than 7 days.

    Nausea, vomitting, abdominal discomfort, diarrhea, or skin rash occurs.

    Excessive irritation of the skin develops.

  • Stop use and ask a doctor if

    Avoid contact with eyes or mucous membranes.

    Do not bandage tightly.

    When using for pain of arthritis:

    In conditions affecting children under 12 years of age

    If red nose is present

    If pain persists for more than 10 days

  • WARNINGS

    For children under 12 years of age, do not  use, consult a doctor.

  • Directions

    Adult and children 12 years of age and older; Remove the clear film backing and apply to the sore area of skin. Use not than 3 times daily.

    Bandage will remain effective after 24 hours and will be even more effective when using after a bath.

    Do not apply to extremely hairy skin. Highly adhesive bandage may hurt skin upon removal.

    Other Information:

    Keep container tightly closed. Once opened, fold the opening and keep pressed. Close with a clip.

    Store at room temperature.

  • INACTIVE INGREDIENTS

    Gelatin, Myrrhm, Sesame Oil, Water and Zinc Oxide

  • PRINCIPAL DISPLAY PANEL

    carton.jpg

  • INGREDIENTS AND APPEARANCE
    PAIN GOODBYE AQUEOUS PATCH 
    methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15667-7396
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE50 mg  in 1000 mg
    2-(L-MENTHOXY)ETHANOL (UNII: 5ZWW23169H) (2-(L-MENTHOXY)ETHANOL - UNII:5ZWW23169H) 2-(L-MENTHOXY)ETHANOL80 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    MYRRH (UNII: JC71GJ1F3L)  
    SESAME OIL (UNII: QX10HYY4QV)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15667-7396-55 in 1 BAG
    1NDC:15667-7396-31000 mg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/26/2011
    Labeler - Austin Biotechnology Inc (656001949)
    Registrant - Austin Biotechnology Inc (656001949)
    Establishment
    NameAddressID/FEIBusiness Operations
    Austin Biotechnology Inc656001949manufacture(15667-7396)