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
  • 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 July 10, 2020

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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 not finalpart34807/10/2020
    Labeler - Natural Essentials, Inc. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-235)
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