FREEZIN COLD TOAST (METHYL SALICYLATE) CREAM [Q.A. LABORATORIES]

FREEZIN COLD TOAST (METHYL SALICYLATE) CREAM [Q.A. LABORATORIES]
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NDC 52099-8000-1
Set ID 80e04a9a-202c-471d-9d76-c0b129cad24f
Category HUMAN OTC DRUG LABEL
Packager Q.A. Laboratories
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredient  Purpose

    Methyl salicylate 31% topical analgesic

    Menthol 11% topical analgesic

  • PURPOSE

    USES temporarily relieves minor body aches and pains of muscle and joints associated with: simple backache

    arthritis sprains bruises strains

  • WARNINGS

    Warnings for external use only

  • DO NOT USE

    Do not use ¡ on wounds ¡ on damaged skin
    ¡ with a heating pad ¡ on a child under 12
    years of age with arthritis-like conditions

  • ASK DOCTOR

    Ask a doctor before use if you have
    redness over the affected area.

  • WHEN USING

    When using this product ¡ avoid contact
    with eyes and mucous membranes ¡ do
    not bandage tightly

  • STOP USE

    Stop use and ask doctor if ■ condition
    worsens or symptoms persist for more than
    7 days ■ symptoms clear up and occur within
    a few days ■ excessive skin irritation occurs

  • 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 (1-800-222-1222)

  • INDICATIONS & USAGE

    Directions ¡ use only as directed
    ¡ adults and children 12 years of age
    or older: apply to af fected area not more
    than 3 to 4 times daily ¡ children under
    12 years of age: ask a doctor

  • SAFE HANDLING WARNING

    Other information
    ■ store between 20-25° C (68-77°F).
    ■ Protect from freezing

  • DOSAGE & ADMINISTRATION

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    DEIONIZED WATER, CETEARYL ALCOHOL,
    ISOPROPYL MYRISTATE, ISOCETYL STEARATE,
    POLYSORBATE 60, SODIUM POLYACRYLOYLDIMETHYL
    TAURATE, PHENOXYETHANOL,
    HYDROGENATED POLYDECENE, CHAMOMILLA
    RECUTITA (MATRICARIA) FLOWER EXTRACT,
    METHYL PARABEN, TRIDECETH-10,
    ROSMARINUS OFFICINALIS (ROSEMARY),
    LEAF EXTRACT, FRANKINCENSE EXTRACT,
    PROPYL PARABEN

  • QUESTIONS

    Questions or comments:
    1-800-4NO-PAIN,
    toastproducts.com
    MFD FOR: Toast Products
    400 Sproul Street,
    Pittsburgh, PA 15136
    MFG IN USA

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    FREEZIN COLD TOAST 
    methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52099-8000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE31 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    ROSEMARY (UNII: IJ67X351P9)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52099-8000-1141 g in 1 TUBE; Type 0: Not a Combination Product06/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/12/2012
    Labeler - Q.A. Laboratories (065361149)
    Registrant - Q.A. Laboratories (065361149)
    Establishment
    NameAddressID/FEIBusiness Operations
    Q.A. Laboratories065361149manufacture(52099-8000)

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