Label: PAIN RELIEF SLEEVE LARGE- menthol patch
PAIN RELIEF SLEEVE EXTRA LARGE- menthol patch
PAIN RELIEF SLEEVE MEDIUM- menthol 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 December 5, 2016

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  • ACTIVE INGREDIENT

    Menthol 16.0%

  • PURPOSE

    Topical Analgesic Patch

  • INDICATIONS & USAGE

    For temporary relief of minor aches and pains of muscles and joints associated with:

    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    For external use only

    When using this product:

    • avoid contact with eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
    • do not use with heating pad
  • STOP USE

    Stop using and ask a doctor

    if redness is present or irritation develops. Condition worsens, or if symptioms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center immediately

  • INSTRUCTIONS FOR USE

    • Adults and children over 12 years: pull sleeve onto knee or large ankles or elbows until the colored section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight.
    • Children 12 years or younger: consult a doctor
  • INACTIVE INGREDIENT

    diethylene glycol monoethyl ether acetate, cetanol, glycerol, glycerol monostearate, methylparaben, 2(2-aminoethoxy) ethanol, sorbitan sesquiolate, sodium polyacrylate, polysorbate 80, aloe barbadensis leaf extract, methyl orange-xylene cyanol solution, ethylenediaminetetracetic acid tetrasodium salt hydrate.

  • DESCRIPTION

    NDC 64092-506-1, ITEM 863906

    GLS

    Personal Care Solutions

    Extra Strength

    Menthol 16%

    Pain Relief Sleeve

    KNEE & Small-Medium ankles & elbows

    Medicated Sleeve

    Pain relieving Lotion on a Breathable Sleeve

    Medium

    Ideal for KNEE

    EXPANDS TO FIT 5" TO 12" (12.5cm to 30.5cm)

    IN CIRCUMFERENCE

    Contains 1 Sleeve Patch

    KNEE

    • ELBOT
    • ANKLE
    • WRIST

    NDC 64092-520-1, ITEM 863920

    GLS

    Personal Care Solutions

    Extra Strength

    Menthol 16%

    Pain Relief Sleeve

    KNEE & Large Ankles & Elbows

    Medicated Sleeve

    Pain relieving Lotion on a Breathable Sleeve

    Large Sleeve

    Ideal for KNEE

    EXPANDS TO FIT 8" TO 24" (20 CM TO 61 CM)

    IN CIRCUMFERENCE

    Contains 1 Sleeve Patch

    KNEE

    • ELBOW
    • ANKLE
    • WRIST

    NDC 64092-520-1, ITEM 863920

    GLS

    Personal Care Solutions

    Extra Strength

    Menthol 16%

    Pain Relief Sleeve

    KNEE & Large Ankles & Elbows

    Medicated Sleeve

    Pain relieving Lotion on a Breathable Sleeve

    XLarge Sleeve

    Ideal for KNEE

    EXPANDS TO FIT 12" TO 28" (30.5 CM to 70 CM)

    IN CIRCUMFERENCE

    Contains 1 Sleeve Patch

    KNEE

    ELBOW
    ANKLE
    WRIST

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 years: pull sleeve onto knee or large ankle or elbow until the colored section of the sleeve is positioned directly over the affected area. sleeve should feel snug, but not tight.

  • PRINCIPAL DISPLAY PANEL

    Med Pain Patch Large pain patchX large pain patch

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF SLEEVE  LARGE
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-520
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYL ORANGE (UNII: 6B4TC34456)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    SOLASULFONE (UNII: H12JE4313S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-520-015 mL in 1 PATCH; Type 0: Not a Combination Product12/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/05/2016
    PAIN RELIEF SLEEVE  EXTRA LARGE
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-544
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYL ORANGE (UNII: 6B4TC34456)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    SOLASULFONE (UNII: H12JE4313S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-544-015 mL in 1 PATCH; Type 0: Not a Combination Product12/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/05/2016
    PAIN RELIEF SLEEVE  MEDIUM
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-506
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYL ORANGE (UNII: 6B4TC34456)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    SOLASULFONE (UNII: H12JE4313S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-506-015 mL in 1 PATCH; Type 0: Not a Combination Product12/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/05/2016
    Labeler - Great Lakes Wholesale, Marketing, and Sales, Inc (361925498)
    Registrant - Illinois Industrial Tool, Inc (628032898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Planet (Suzhou) Medical Products Co., Ltd528194366manufacture(64092-506, 64092-520, 64092-544)
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