PAINZONE LIGHT CREAM [MEDZONE PRODUCTS LLC]

PAINZONE LIGHT CREAM [MEDZONE PRODUCTS LLC]
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NDC 70338-651-01
Set ID 85689a6e-1265-22a9-e053-2a91aa0aecfd
Category HUMAN OTC DRUG LABEL
Packager MEDZONE PRODUCTS LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredient

    Active IngredientUse
    Menthol 3.5%Topical Analgesic

  • Uses

    Uses:

    • For temporary relief of minor aches and pains. Used for muscle and joint pain associated with arthritis, backache, strains, sprains
  • Do Not Use

    Do not use:

    • On wounds or damaged skin
    • With a heating pad
    • On children under 12 years of age
    • If pregnant or breast feeding
  • Stop use and ask a physicinan if:

    Stop use and ask a physician if:

    • Conditiion worsens or symtops persist for more than 7 days
    • Symptoms clear up and occur again within a few days
    • Excessive skin irritation occurs
  • Directions

    Directions
    Use only as directed
    Adults and children 12 years of age and older, rub a thin layer to affected area 3-4 times daily
    Children under 12 years of age consult a physician
    Wash hands after applying

  • Storage

    Store at 68-86 degrees with lid tightly closed

  • Inactive Ingredient

    Alcohol Denaturated, Camphor, Carbomer, Ethylhexylglycerin, Glycerin, Jaanese Green tea ( Camellia Sinesis) Extract, Laureth-4, Petrolatum, Pineapple (Ananas Sativus) Extract, Polysorbate 80, Propylene Glycol, Phenoxyethanol, Triethanolamine, Water

  • Warnings For External Use Only:


    Warnings For External Use Only:

    • Avoid contact with eyes and mucous membranes. Do not bandage tightly
  • Distributed By

    Distributed by: MedZone

    Lenexa, Kansas

    Ph 913-948-9663

    www.medzonecorp.com

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    Pain Zone 1Pain Zone 2

  • INGREDIENTS AND APPEARANCE
    PAINZONE LIGHT 
    painzone light cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-651
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LAURETH-4 (UNII: 6HQ855798J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    ALCOHOL (UNII: 3K9958V90M)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70338-651-01113 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2019
    Labeler - MEDZONE PRODUCTS LLC (080083739)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Laboratories LLC016754201manufacture(70338-651)

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