FAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]

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FAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]
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NDC 66902-016-01, 66902-016-03, 66902-016-04, 66902-016-05, 66902-016-16, 66902-016-32
Set ID a96e3e41-871c-4cf3-93b6-af2a6246ded8
Category HUMAN OTC DRUG LABEL
Packager Natural Essentials Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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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