DUANE READE HOT AND COLD ROLL-ON (METHYL SALICYLATE AND MENTHOL) GEL [DUANE READE]

DUANE READE HOT AND COLD ROLL-ON (METHYL SALICYLATE AND MENTHOL) GEL [DUANE READE]
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NDC 24488-023-03
Set ID d4a02427-127f-4d76-9c02-bf2efcc84c78
Category HUMAN OTC DRUG LABEL
Packager Duane Reade
Generic Name
Product Class
Product Number
Application Number PART348
  • 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

  • When using this product

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

    purified water/aqua/eau, sd alcohol 40-b,

    propylene glycol, isopropyl myristate,

    glycerin, triethanolamine, carbomer

  • Allergy alert:

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

  • PRINCIPAL DISPLAY PANEL

    Placeholder Text


    DR_Hot-n-Cold_Rollon_label
  • INGREDIENTS AND APPEARANCE
    DUANE READE  HOT AND COLD ROLL-ON
    methyl salicylate and menthol gel
    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 SALICYLATE21.46 mL  in 74 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.62 mL  in 74 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-023-0374 mL in 1 BOTTLE, WITH APPLICATOR
    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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