ZIMS LIDO FREEZE (MENTHOL, UNSPECIFIED FORM AND LIDOCAINE) GEL [NATURAL ESSENTIALS, INC]

ZIMS LIDO FREEZE (MENTHOL, UNSPECIFIED FORM AND LIDOCAINE) GEL [NATURAL ESSENTIALS, INC]
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NDC 66902-230-03
Set ID 5d405cc2-907b-49dd-a5b6-118dfb370043
Category HUMAN OTC DRUG LABEL
Packager NATURAL ESSENTIALS, INC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine 4%

    Menthol USP 1 %

  • Purpose

    Topical Analgesic

    Topical Analgesic

  • Use

    • For the temporary relief of pain.
  • Warnings

    For external use only

    Do not use

    • if you are allergic to any ingredient in this product
    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    Ask a doctor or pharmacist before use if you are

    • using blood thinning medications, steroids or non-steroidal anti-inflammatory drugs (NSAIDS)

    When using this product

    • do not use other topical products
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly or apply local heat (such as heating pads) to area of use or with a medicated patch
    • keep away from excessive heat

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling or blistering where product was applied

    If pregnant or breast feeding ask a physician before use.

    Keep out of reach of children. If put in the mouth, get medical help or contact a poison control center right away.

  • Directions

    Adults/children 12 years and older

    • Apply to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    • After applying, wash hands with soap and water
    • Under age 12, consult a physician before use
  • Other information

    Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Deionized Water, Disodium EDTA, Glycerine, Isopropyl Alcohol, Propylene Glycol.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - 10mg of Menthol and 40 mg of Lidocaine Canister Label

    ZIM'S
    LIDO-
    FREEZE

    LIDOCAINE & MENTHOL

    PAIN RELIEF

    Lidocaine & Menthol
    formula in as easy to use
    roll-on applicator

    Nature Science

    89 mL (3 fl oz)

    Principal Display Panel - 10mg of Menthol and 40 mg of Lidocaine Canister Label
  • INGREDIENTS AND APPEARANCE
    ZIMS LIDO FREEZE 
    menthol, unspecified form and lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-230-0389 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2016
    Labeler - NATURAL ESSENTIALS, INC (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC947484713MANUFACTURE(66902-230)

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