Label: FAST FREEZE- menthol spray 

  • Label RSS
  • NDC Code(s): 66902-015-04, 66902-015-16, 66902-015-27, 66902-015-44
  • Packager: Natural Essentials Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Menthol 10%

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  • Purpose

    Cooling Pain Relief

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  • Uses

    Temporary relief of minor aches and pains of muscles and joints associated with:

    • Simple backache
    • Arthritis
    • Strains
    • Sprains
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  • Warnings

    • For external use only
    • Flammable
    • Keep away from excessive heat or open flame
    • Avoid spraying in eyes
    • Contents under pressure. Do not puncture or incinerate container. Do not store at temperature above 120°F (48°C)

    Do not use

    • With heating pad or device
    • With ointments, creams, sprays or liniments
    • On wounds, damaged skin or irritated skin

    Ask a doctor before use if you

    • Have sensitive skin
    • Are pregnant or breastfeeding

    When using this product

    • Avoid contact with eyes or mucous membranes
    • Do not bandage tightly

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
    • Irritation develops

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Adults/Children 2 years and older:

    • Spray on the affected area not more than 3 to 4 times daily
    • Shake well before use

    Children under 2 years old: Consult a physician.

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  • Other information

    • Replace cap after use
    • Store in a cool, dry place
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  • Inactive ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Extract, Ilex Paraguariensis Leaf Extract,SDA-39c Alcohol, Tocopherol (Vitamin E) Acetate, Water

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  • Questions?

    Call 317-228-1144 or visit www.Bell-Horn.com or www.fastfreeze.com

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Bottle Label

    FAST FREEZE®

    Naturally
    Cool

    Pain Relieving

    Continuouse Spray

    Helps to relieve

    • Sore muscles
    • Strains & sprains
    • Joint pain

    ………………………………….

    • Invigorating cooling menthol
    • Greaseless & stain-free
    • Natural ingredients include
      Vitamin E, Aloe & llex

    ………………………………….

    4 oz (118 mL)

    Principal Display Panel – Bottle Label
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  • INGREDIENTS AND APPEARANCE
    FAST FREEZE 
    menthol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66902-015
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ILEX PARAGUARIENSIS LEAF  
    ISOPROPYL ALCOHOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66902-015-27 1 g in 1 BOTTLE, PUMP
    2 NDC:66902-015-04 1 g in 1 BOTTLE, PUMP
    3 NDC:66902-015-44 1 g in 1 CAN
    4 NDC:66902-015-16 1 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/01/2013
    Labeler - Natural Essentials Inc. (947484713)
    Establishment
    Name Address ID/FEI Business Operations
    Natural Essentials Inc. 947484713 MANUFACTURE(66902-015)
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