Label: FREEZIN COLD TOAST- methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 21, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient  Purpose

    Methyl salicylate 31% topical analgesic

    Menthol 11% topical analgesic

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  • PURPOSE

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

    arthritis sprains bruises strains

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  • WARNINGS

    Warnings for external use only

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  • 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

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  • ASK DOCTOR

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

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  • WHEN USING

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

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  • 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

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  • 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)

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  • 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

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  • SAFE HANDLING WARNING

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

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  • DOSAGE & ADMINISTRATION

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

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  • 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

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  • QUESTIONS

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

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  • INGREDIENTS AND APPEARANCE
    FREEZIN COLD TOAST 
    methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52099-8000
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 31 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 11 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52099-8000-1 141 g in 1 TUBE; Type 0: Not a Combination Product 06/12/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/12/2012
    Labeler - Q.A. Laboratories (065361149)
    Registrant - Q.A. Laboratories (065361149)
    Establishment
    Name Address ID/FEI Business Operations
    Q.A. Laboratories 065361149 manufacture(52099-8000)
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