Label: FAST FREEZE- menthol gel

  • NDC Code(s): 66902-016-01, 66902-016-03, 66902-016-04, 66902-016-05, view more
    66902-016-16, 66902-016-32
  • Packager: Natural Essentials Inc.
  • 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 November 15, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 3.5%

  • Purpose

    Cooling Pain Relief

  • Uses

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

    • Simple backache
    • Arthritis
    • Strains
    • Sprains
  • Warnings

    • For external use only
    • Flammable
    • Keep away from excessive heat or open flame

    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.

  • Directions

    Adults/Children 2 years and older:

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

    Children under 2 years old: Consult a physician.

  • Other information

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

    Aloe Barbadensis (Aloe Vera) Leaf Extract, Carbomer, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tocopherol (Vitamin E) Acetate, Triethanolamine, Water.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Bottle Label

    FAST FREEZE®

    Naturally
    Cool

    Pain Relieving Roll-On

    Helps to relieve

    • Sore muscles
    • Strains & sprains
    • Joint pain

    ………………………………….

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

    ………………………………….

    3 oz (89 mL)

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    FAST FREEZE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-016-051 g in 1 PACKET; Type 0: Not a Combination Product01/01/2013
    2NDC:66902-016-031 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2013
    3NDC:66902-016-041 g in 1 TUBE; Type 0: Not a Combination Product01/01/2013
    4NDC:66902-016-161 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2013
    5NDC:66902-016-321 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2013
    6NDC:66902-016-011 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2013
    Labeler - Natural Essentials Inc. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Essentials Inc.947484713MANUFACTURE(66902-016)
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