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Fast Freeze (Natural Essentials Inc.)

Available Formats

Dosage Form Package Information Links
GEL 1 g in 1 BOTTLE, PUMP (66902-000-32) Label Information
GEL 1 g in 1 TUBE (66902-000-04) Label Information
GEL 1 g in 1 BOTTLE, PUMP (66902-000-16) Label Information
GEL 1 g in 1 PACKET (66902-000-05) Label Information
GEL 1 g in 1 BOTTLE (66902-000-03) Label Information
GEL 1 g in 1 BOTTLE, PUMP (66902-000-01) Label Information

Complete Fast Freeze Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredients

    Camphor 0.2%, 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:
    • Rub 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, Pump Label

    NEW!
    BELL-HORN
    FAST FREEZE
    ®
    PAIN RELIEVING GEL

    FREEZES PAIN
    INSTANTLY!

    HELPS TO RELIEVE:
    - SORE MUSCLES
    - STRAINS & SPRAINS
    - JOINT PAIN
    (GREAT FOR ARTHRISTIS)

    16 oz (473 mL)

    Principal Display Panel – Bottle, Pump Label

  • INGREDIENTS AND APPEARANCE
    FAST FREEZE 
    camphor (natural), menthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-000
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 2 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 35 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66902-000-05 1 g in 1 PACKET
    2 NDC:66902-000-03 1 g in 1 BOTTLE
    3 NDC:66902-000-04 1 g in 1 TUBE
    4 NDC:66902-000-16 1 g in 1 BOTTLE, PUMP
    5 NDC:66902-000-32 1 g in 1 BOTTLE, PUMP
    6 NDC:66902-000-01 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 04/01/2010
    Labeler - Natural Essentials Inc. (947484713)
    Establishment
    Name Address ID/FEI Business Operations
    Natural Essentials Inc. 947484713 MANUFACTURE