Label: FAST FREEZE LIDOCAINE- lidocaine spray

  • NDC Code(s): 66902-225-04
  • 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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  • ACTIVE INGREDIENTS

    Lidocaine 4%

  • PURPOSE

    Topical Anesthetic

  • USES

    Temporary relief of minor pain

  • WARNINGS

    For external use only

    DO NOT USE

    • In large quantities, particularly over raw surfaces or blistered areas

    WHEN USING THIS PRODUCT

    • Keep out of eyes
    • Use only as directed
    • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F

    STOP USE AND ASK A DOCTOR IF

    • Condition worsens
    • Symptoms persist for more than 7 days or 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

    Shake well

    • Adults and children over 12 years:

    Apply a thin layer to affected area not more than 3 to 4 times daily

    • To apply to face, spray into palm of hand and gently apply
    • Children under 12 years of age, ask a doctor
  • INACTIVE INGREDIENTS

    Acrylates/C10-30 Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Deionized Water, Diazolidinyl Urea. Dimethicone, Disodium Cocamphodipropionate. Disodium EDTA, Glycerin. Propylene Glycol, SDA 39C Alcohol, Tocopheryl Acetate, Triethanolamine.

  • Principal Display Panel – 118 mL Can Label

    FAST FREEZE®

    MAXIMUM STRENGTH
    LIDOCAINE
    CONTINUOUS SPRAY

    UNSCENTED

    • Numbing relief
    • No mess, greaseless & stain-free
    • Natural ingredients include
      Vitamin E and Aloe
    • For the temporary relief of
      minor aches and pains of muscles
      and joints; associated with backache,
      arthritis, strains and sprains
    • Paraben Free
    • Fast Drying

    3 oz (89 mL)

    Principal Display Panel – 118 mL Can Label
  • INGREDIENTS AND APPEARANCE
    FAST FREEZE LIDOCAINE 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-225
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    CUCUMBER (UNII: YY7C30VXJT)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-225-04118 mL in 1 CAN; 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(66902-225)
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