WALGREENS COOL AND HEAT MUSCLE AND JOINT RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [WALGREEN COMPANY]

WALGREENS COOL AND HEAT MUSCLE AND JOINT RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [WALGREEN COMPANY]
PDF | XML

NDC 0363-0147-30
Set ID 70712f94-0730-4b6b-a1b6-0b3caa80c736
Category HUMAN OTC DRUG LABEL
Packager WALGREEN COMPANY
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients                                                       Purpose

    Menthol 10%............................................................Topical Analgesic

    Methyl Salicylate 30%...............................................Topical Analgesic

  • PURPOSE

    Uses temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps

  • WARNINGS

    Warnings For external use only

    Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use

  • WHEN USING

    When using this product

    • Use only as directed
    • Do not bandage tightly or use with a heating pad
    • Avoid contact with eyes or mucous membranes
    • Do not apply to wounds, damaged, broken or irritated skin
  • STOP USE

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • Redness is present
    • Irritation develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    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
    • Close cap tightly after use
    • Keep carton as it contains important information
    • Children 12 years or younger: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients DEA-cetyl phosphate, isopropyl myristate, methylparaben, polysorbate 60, propylparaben, purified lanolin, purified water, stearic acid, stearyl alcohol, trolamine

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    WALGREENS COOL AND HEAT MUSCLE AND JOINT RELIEF  
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0147
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0147-301 in 1 CARTON
    185 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/31/2013
    Labeler - WALGREEN COMPANY (008965063)