Label: NOPEN COOL- glycol salicylate, levomenthol 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 August 20, 2018

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  • Active Ingredients (in each patch)

    Glycol Salicylate 35mg

    L-Menthol 35mg

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relieves mild to moderate aches and pains of muscles and joints associated with:

    ■simple backache ■bruises ■sprains ■shoulder pains ■muscle pains ■arthritis

  • Warnings

    For external use only

    Do not use

    ■on the face or rashes ■wounds or damaged skin ■with a heating pad ■if you are allergic to salicylates

    ■when sweating (Such as from exercise or heat) ■on children under 12 years of age

    Ask a doctor before use if

    ■ you have redness over the affected area ■ pregnant or breast feeding

    When using this product

    ■ wash hands after applying or removing patch. ■ avoid contact with eyes or mucous membranes. ■ if eye contact occurs, rinse thoroughly with water. ■ do not bandage tightly

    Stop use and ask a doctor if

    ■ rash, itching or skin irritation develops ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days

    Keep out of reach of children

    Package not child-resistant. Dispose of the used patches after folding sticky ends together. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    ■ clean and dry affected area before applying

    ■ peel off protective backing and apply sticky side to affected area and leave in place for up to 8 to 12 hours

    ■ remove used patch from skin before applying a new patch

  • Other Information

    ■ store at 20℃ to 25℃ (68℉ to 77℉)

    ■ avoid storing product in direct sunlight

    ■ protect product from excessive moisture

    ■ some individuals may not experience pain relief until several hours after applying the patch

  • Inactive ingredients

    Acryl Adhesive, Nonwoven Polyester Fabric, Paper Release Liner, Rubber Adhesive, Vanillyl Butyl Ether

  • Questions or comments?

    Call 1-562-281-5888 Monday-Friday 9AM-4PM ET

    Distributed by: Jemian USA Inc

  • Principal Display Panel-5 Patches

    JW Pharmaceutical

    NOPEN

    Cool

    Neutral sensation type Glycol Salicylate/ L-Menthol

    5 Patches

    2.7 in x 3.9 in (7 cm x 10 cm)

    NOPEN Cool Patch

  • INGREDIENTS AND APPEARANCE
    NOPEN COOL 
    glycol salicylate, levomenthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69365-006
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOL SALICYLATE (UNII: 3I1VBB7AXH) (GLYCOL SALICYLATE - UNII:3I1VBB7AXH) GLYCOL SALICYLATE35 mg
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM35 mg
    Inactive Ingredients
    Ingredient NameStrength
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.70-1.00) (UNII: 645M2T7FHZ)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLE (2.7 in x 3.9 in (7 cm x 10 cm)) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69365-006-015 in 1 POUCH; Type 0: Not a Combination Product08/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/17/2018
    Labeler - JW HOLDINGS CORPORATION (631094492)
    Registrant - JW HOLDINGS CORPORATION (631094492)
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