GOOD SENSE HOT AND COLD MEDICATED PATCH (MENTHOL) PATCH [GOOD SENSE]

GOOD SENSE HOT AND COLD MEDICATED PATCH (MENTHOL) PATCH [GOOD SENSE]
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NDC 50804-124-13
Set ID 1b16c3e5-a29f-4043-94e6-0a0e0ea3d93e
Category HUMAN OTC DRUG LABEL
Packager GOOD SENSE
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredient ...............................................................................................Purpose
    Menthol 5%...............................................................................................Topical Analgesic

  • INACTIVE INGREDIENT

    CMC, Dihydroxy aluminum Aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control

  • INDICATIONS & USAGE

    Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis
    ■ muscle strains ■ muscle sprains ■ bruises ■ cramps

  • WARNINGS

    For External Use Only.

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

    Wear one patch up to 8 hours. Repeat as necessary, but no more than 4 times daily. Reseal pouch after opening.

    Children 12 years or younger: Consult a physician.

  • PURPOSE

    Topical Analgesic

  • When using this product

    Use only as directed ■ Don’t bandage tightly or use with heating pad
    ■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.

  • Stop use and ask a doctor

    If condition worsens ■ If redness is present ■ If irritation develops
    ■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

  • If pregnant or breastfeeding

    ask a health professional before use.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GOOD SENSE HOT AND COLD MEDICATED PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-124-135 in 1 BOX01/01/2018
    19 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2018
    Labeler - GOOD SENSE (076059836)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(50804-124)

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