Label: ZIMS LIDO FREEZE- menthol, unspecified form and lidocaine gel

  • 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 August 1, 2016

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!