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

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FAST FREEZE (CAMPHOR (NATURAL), MENTHOL) GEL [NATURAL ESSENTIALS INC.]
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NDC 66902-000-01, 66902-000-03, 66902-000-04, 66902-000-05, 66902-000-16, 66902-000-32
Set ID 60c94da8-6c00-4544-a9a6-a3e87ebabd68
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

    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)2 mg  in 1 g
    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:66902-000-051 g in 1 PACKET; Type 0: Not a Combination Product04/01/2010
    2NDC:66902-000-031 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2010
    3NDC:66902-000-041 g in 1 TUBE; Type 0: Not a Combination Product04/01/2010
    4NDC:66902-000-161 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2010
    5NDC:66902-000-321 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2010
    6NDC:66902-000-011 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2010
    Labeler - Natural Essentials Inc. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Essentials Inc.947484713MANUFACTURE(66902-000)
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