Label: DUANE READE HOT AND COLD BALM- methyl salicylate and menthol salve

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 28, 2011

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  • Active Ingredients Purpose

    Methyl Salicylate 29% ...Topical Analgesic
    Menthol 7.6% ................Topical Analgesic

  • Uses

    temporarily relieves the minor pains associated with:

    • arthritis
    • cramps
    • bruises
    • sprains
    • backache
  • Warnings

    For external use only

  • Allergy alert:

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

  • When using this product

    • use only as directed
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly or with a heating pad
    • do not apply to wounds or damaged skin
  • 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 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 over 12 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 4 times daily
    children under 12 years: ask a doctor.
  • Inactive ingredients

    petrolatum, paraffin

  • PRINCIPAL DISPLAY PANEL

    Placeholder text

    DR_hot_and_cold_balm_label

  • INGREDIENTS AND APPEARANCE
    DUANE READE  HOT AND COLD BALM
    methyl salicylate and menthol salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE30.16 mL  in 104 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.90 mL  in 104 mL
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-023-02104 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/28/2011
    Labeler - Duane Reade (961956229)
    Registrant - Creations Garden Natural Products Inc. (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products Inc.961956229manufacture
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