PAIN RELIEF SLEEVE LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE EXTRA LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE MEDIUM (MENTHOL) PATCH [GREAT LAKES WHOLESALE, MARKETING, AND SALES, INC]

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  • PAIN RELIEF SLEEVE LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE EXTRA LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE MEDIUM (MENTHOL) PATCH [GREAT LAKES WHOLESALE, MARKETING, AND SALES, INC]

PAIN RELIEF SLEEVE LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE EXTRA LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE MEDIUM (MENTHOL) PATCH [GREAT LAKES WHOLESALE, MARKETING, AND SALES, INC]
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NDC 64092-506-01, 64092-520-01, 64092-544-01
Set ID 42f0f24c-97e0-4a3d-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Great Lakes Wholesale, Marketing, and Sales, Inc
Generic Name
Product Class
Product Number
Application Number PART348
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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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