PAIN GOODBYE AQUEOUS PATCH (METHYL SALICYLATE) PATCH [AUSTIN BIOTECHNOLOGY INC]

PAIN GOODBYE AQUEOUS PATCH (METHYL SALICYLATE) PATCH [AUSTIN BIOTECHNOLOGY INC]
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NDC 15667-7396-3, 15667-7396-5
Set ID 0e8b325d-4b41-4f9f-a778-b9b5d1c8525f
Category HUMAN OTC DRUG LABEL
Packager Austin Biotechnology Inc
Generic Name
Product Class
Product Number
Application Number PART348
  • 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)

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