4JOINTZ (MENTHOL) CREAM [ARP(USA) PTY LTD]

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4JOINTZ (MENTHOL) CREAM [ARP(USA) PTY LTD]
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NDC 71282-011-27
Set ID 37437b26-17ae-47f4-a23a-6fda95d3aa0b
Category HUMAN OTC DRUG LABEL
Packager ARP(USA) Pty Ltd
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Menthol 1.5%

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Uses Temporarily relieves the aches and pains of muscles and joints associated with:

    ■ arthritis ■ simple backache  ■ strains ■ bruises ■ sprains

  • WARNINGS

    Warnings For external use only.

  • DO NOT USE

    Do not use

    ■ on open wounds or abraded skin or while nursing

    ■ on a child under 12 years of age with arthritis-like conditions

    ■ near the eyes or on mucous membranes

    ■ with a heating pad or bandage tightly over the area

  • ASK DOCTOR

    Discontinue use and consult a doctor if

    ■ conditions worsen or symptoms persists for more than

      7 days or clear up and occur again within a few days

    ■ redness or irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed,

    get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions Use only as directed

    ■ adults & children 12 years and older: massage gently

    into affected joints

    ■ apply three (3) times daily for optimal results

  • OTHER SAFETY INFORMATION

    Other Information store below 30°C (86°F)

  • Inactive Ingredients

    Inactive ingredients Aloe barbadensis leaf gel,

    caprylyl glycol, castor oil, cetyl alcohol, deionized

    water, dimethicone, disiloxane,eucalypyus oil,

    frankincense oil, glycerin, glyceryl stearate, olive oil,

    PEG-100 stearate, phenoxyethanol, propylene glycol,

    SD alcohol, sodium hydroxide, sorbic acid, symphytum

    officinale (comfrey), tannic acid, urea, xanthan gum  

  • Questions

    1-844-4JOINTZ (1-844-456-4689)

  • 4JOINTZ®

    Principal Display Panel

    Live Pain Free

    4JOINTZ®
    FREEDOM TO MOVE

    Pain Relief Cream

    www.4jointz.com

     2 X 3.5 oz [100g] tubes – 7 oz [200g] total

    Clinically Tested Long Lasting Results

    4JOINTZ®
    FREEDOM TO MOVE

    Uniquely Formulated for Painful, Stiff & Swollen Joints

    4JOINTZ®
    FREEDOM TO MOVE

    Nature & Science Combined
    4JOINTZ®
    FREEDOM TO MOVE

    Nature & Science Combined

    0  80119 61913  3

    Manufactured for ARP (USA) Pty Ltd, 2A, Ground Floor, 15 Lake St.

    Varsity Lakes QLD 4227 Australia. Visit www.4Jointz.com for further

    details and to see how 4Jointz has helped people just like you.

    Net wt. 7oz (200g). Patent: www.4jointz.com/patent

    Made in the USA of US and imported materials

    4Jointz Box V5

    ↓Inner Package↓

    4Jointz Tube V5

    res

  • INGREDIENTS AND APPEARANCE
    4JOINTZ 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71282-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
    TANNIC ACID (UNII: 28F9E0DJY6)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71282-011-272 in 1 PACKAGE01/31/2017
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/31/2017
    Labeler - ARP(USA) Pty Ltd (744244375)
    Registrant - ARP(USA) Pty Ltd (744244375)
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