ZIMS MAX HEAT (METHYL SALICYLATE) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]

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ZIMS MAX HEAT (METHYL SALICYLATE) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]
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NDC 54273-001-01
Set ID 68b73644-2383-4217-a6b2-d959a47c8727
Category HUMAN OTC DRUG LABEL
Packager KOBAYASHI Healthcare International, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Methyl salicylate 20%

  • Purpose

    Topical analgesic

  • Uses

    For temporary relief of minor aches & pains of muscles & joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Allergy alert

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    Flammable

    Keep away from fire or flame and heated surfaces.

    Do not use

    • on wounds or damaged skin or irritated skin
    • with a heating pad or TENS device
    • after expiry date

    When using this product

    • do not bandage tightly
    • do not use otherwise than as directed
    • avoid contact with eyes or mucous membranes

    Stop use and ask a doctor if

    • conditions worsen
    • rash, itching, redness or excessive irritation of the skin develops
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    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.

  • Directions

    Adults and children 12 years of age and over:

    • apply to affected area not more than 3 to 4 times daily

    Children under 12 years of age: consult a doctor

  • Other information

    • store in a cool place away from direct sunlight
    • store with lid closed tightly
  • Inactive ingredients

    alcohol, capsicum extract, peppermint oil

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    KOBAYASHI Consumer Products, LLC
    P.O. Box 1191, Dalton, GA 30722

  • PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton

    ZIM'S™
    MAX
    HEAT

    Fast Acting
    Topical Analgesic LIQUID

    STIFF NECK &
    SHOULDERS

    Soft Sponge Applicator

    DEEP
    PENETRATING
    HEAT     relieves
    tense muscles

    Methyl salicylate 20%

    2.7 fl oz (80mL)

    PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX HEAT 
    methyl salicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54273-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CAPSICUM (UNII: 00UK7646FG)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54273-001-011 in 1 CARTON04/01/2018
    169 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34804/01/2018
    Labeler - KOBAYASHI Healthcare International, Inc. (156391729)
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