Label: FAST FREEZE LIDOCAINE ROLL-ON- lidocaine hydrochloride, benzyl alcohol liquid

  • NDC Code(s): 66902-235-03
  • Packager: Natural Essentials, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 4, 2024

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS

    Lidocaine HCl 4%

    Benzyl Alcohol 10%

  • PURPOSE

    Topical Anesthetic

    Topical Anesthetic

  • USES

    Temporary relief of minor pain

  • WARNINGS

    For external use only

    FLAMMABLE:Keep away from fire or flame

    DO NOT USE

    • on wounds or damaged skin
    • in large quantities
    • with a heating pad
    • if you are allergic to any ingredients of this product

    WHEN USING THIS PRODUCT

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    STOP USE AND ASK A DOCTOR IF

    • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.

    KEEP OUT OF REACH OF CHILDREN AND PETS.If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Adults and children 12 years of age and over
    • clean and dry affected area
    • apply to affected area not more than 3 to 4 times daily children 12 years or younger ask a doctor
  • OTHER INFORMATION

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
    • Store with lid closed tightly
  • INACTIVE INGREDIENTS

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Citric Acid, Deionized Water, SDA 40-B Alcohol, Tromethamine

  • Principal Display Panel – 89 mL Container Label

    FAST FREEZE ®

    MAXIMUM STRENGTH
    LIDOCAINE
    ROLL-ON

    UNSCENTED

    • Numbing relief
    • No mess, greaseless & stain-free
    • Natural ingredients include Aloe
    • For the temporary relief of
      minor aches and pains of muscles
      and joints; associated with backache,
      arthritis, strains and sprains
    • Paraben Free
    • Plus 10% Benzyl Alcohol

    3 oz (89 mL)

    Principal Display Panel – 89 mL Container Label
  • INGREDIENTS AND APPEARANCE
    FAST FREEZE LIDOCAINE ROLL-ON 
    lidocaine hydrochloride, benzyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-235-0389 mL in 1 CONTAINER; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/10/2020
    Labeler - Natural Essentials, Inc. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713manufacture(66902-235)
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