Label: GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH 4 LODOCAINE BACK- lidocaine patch

  • NDC Code(s): 69771-010-05
  • Packager: Geri-Gentle Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 10, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Lidocaine 4%

    Purpose

    Topical anesthetic

  • Uses

    For temporary relief of pain

  • Warnings:

    For external use only

    Do not use

    • More than 1 patch at a time
    • on wounds or damaged skin
    • with heating pad
    • if you are allergic to any ingredient of this product.

    When using this product

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

    Stop use and ask a doctor if

    • localized skin reactions, such as rash, itching, redness, pain swelling and blistering develop
    • Condition worsens
    • 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 care 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 over 12 years:

    • Clean and dry affected area.
    • remove film from patch and apply to skin
    • apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
    • wear each patch up to 8 hours maximum.
    • consult a physcian Children 12 years or younger:
  • Other information:

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
  • Inactive ingredients:

    Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

  • Package Labeling:

    Outer PackageInner PackageLabel0

  • INGREDIENTS AND APPEARANCE
    GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH 4 LODOCAINE BACK 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-010
    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
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-010-054 in 1 POUCH07/16/2022
    10.0242 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/16/2022
    Labeler - Geri-Gentle Corporation (080367686)
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

More Info on this Drug

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