PAIN RELIEF LIQUID (MENTHOL) LIQUID [GREAT LAKES WHOLESALE, MARKING, AND SALES, INC.]

PAIN RELIEF LIQUID (MENTHOL) LIQUID [GREAT LAKES WHOLESALE, MARKING, AND SALES, INC.]
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NDC 64092-402-02
Set ID 42eef404-1d3a-5991-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Great Lakes Wholesale, Marking, and Sales, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Menthol 16%

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

    temporariy relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps
  • WARNINGS

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • a transient burning sensation may occur upon application but generally disappears in several days
    • if severe burning sensation occurs, discontinue use immediately
    • do not expose the area treated with product to heat or direct sunlight

    Flammable

    • keep away from fire or flame
  • STOP USE

    stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again witin a few days sy
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help, or contact a Poison control Center right away

  • INSTRUCTIONS FOR USE

    Adults and children over 12 years;

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 3-4 times daily
    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    children 12 years or younger: ask a doctor

  • INACTIVE INGREDIENT

    acrylates/C10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol 40 (3

    0%), water (245-256)

  • DESCRIPTION

    Personal Care Solutions

    Maximum Strength

    Pain Relief Liquid

    with no mess roll-on applicator

    Long lasting pain relief

    • Powerful, fast acting formula
    • Deep Penetrating Quick Drying
    • Roller Ball Keeps Hands Clean

    2.5 fl. oz. (73 ml)

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 years

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed int skin
    • repeat as necessary, but no more than 3-4 times daily.
  • PRINCIPAL DISPLAY PANEL

    Liquid Roll on pain relief

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF LIQUID 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.16 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-402-0273 mL in 1 BOTTLE, WITH APPLICATOR; 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, Marking, and Sales, Inc. (361925498)
    Registrant - Illinois Industrial Tool, Inc (628032898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Dedi Medical Device Co., Ltd.421353662manufacture(64092-402)

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