Label: SOCALM PAIN RELIEVING - methyl salicylate patch 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/11

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

  • Active Ingredients

    Methyl Salicylate 10%

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  • Purpose

    Topical Analgesic

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  • Uses

    for the temporary relief of 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.

    Avoid contact with the eyes.

    When using this product

    When using this product

    Do not use otherwise than as directed.

    Do not apply to wounds or damaged skin.

    Do not bandage tightly.

    Stop use and ask a doctor if

    Redness is present.

    Excessive irritation of skin develops.

    Condition worsens

    symptoms persist for more than 7 days or clean up and occur again within a few days

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children

    if swallowed get medical help

    contact Poison Control Center right away

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  • Directions

    Open pouch and remove.

    Pull woven wrap containing external analgesic pads over knee, positioning on either side of affected area.

    Adults and children 3 years of age and older: apply to affected area not more than 3 to 4 times daily.

    Children under 3 years of age: Consult a doctor.

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  • Other information

    Store away from direct sunlight.

    For your protection, this patch has been sealed in an aluminum pouch.

    Do not use if tamper evident seal is missing, tampered, broken or destroyed.

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  • Inactive Ingredients

    Citronella Oil, clove oil, coriander seed oil, macadamia nut oil, mandarin oil, polyether block amide and rosemary oil.

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  • Questions?

    Write to AB7 America 2645 Executive Park Drive Weston, Fl 33331

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  • SPL UNCLASSIFIED SECTION

    Dr. Rechell

    FRANCE

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  • SPL UNCLASSIFIED SECTION

    soCALM

    Fits the natural contour

    of the knee.

    Can be reused

    Once opened, use within

    1 MONTH


    Size       Knee Circumfrence

    1            12 - 14 in
    2            14.1 - 17 in
    3            17.1 - 20 in



    Manufactured by:
    AB7 industries
    BP9 - Chemin des Monges
    Deyme F-31450
    Product of France
    www.ab7-industries.com
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  • PRINCIPAL DISPLAY PANEL


    MADE IN FRANCE

    soCALM Knee Pain Relieving Patch

    Knee



    born with

    Technology



    Essential oil based active ingredient

    Penetrating pain relief



    1 embedded

    textile patch

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  • INGREDIENTS AND APPEARANCE
    SOCALM PAIN RELIEVING 
    methyl salicylate patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52815-121
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CITRONELLA OIL  
    CLOVE OIL  
    CORIANDER OIL  
    MACADAMIA OIL  
    MANDARIN OIL  
    ROSEMARY OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52815-121-03 1 in 1 BOX
    1 0.2 g in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/24/2011
    Labeler - AB7 Industries (381206077)
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