Label: FOSTER AND THRIVE- lidocaine patch

  • NDC Code(s): 70677-1188-1
  • Packager: STRATEGIC SOURCING SERVICES, LLC
  • 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 September 25, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Lidocaine 4%..................................................................Topical anesthetic

  • PURPOSE

    Use

    temporarily relieves minor pain

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • more than 1 patch on your body at a time
    • at the same time as other topical analgesics
    • on damaged skin, or puncture wounds
    • for more than one week without consulting a doctor
    • if you are allergic to any ingredients of this product
  • WHEN USING

    When using this product

    • use only as directed. Read and follow all directions and warnings on this label.
    • do not allow contact with the eyes
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • avoid the patch getting wet for better adhesion
    • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain enough lidocaine to cause serious or life-threating problems.
  • STOP USE

    Stop use and ask a doctor if

    • skin reactions occur, such as pain, swelling, rash, redness, itching, irritation, or blistering where the product was applied
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • condition worsens
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children over 12 years:
    • clean and dry affected area
    • expose a portion of the patch by firmly grasping an edge or corner and gently pull apart until backing separates
    • position and apply exposed portion of the patch to affected area
    • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
    • use 1 patch at a time, not more than 3 to 4 times daily
    • children under 12 years or younger: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate (2,500,000 MW), tartaric acid, titanium dioxide

  • DOSAGE & ADMINISTRATION

    Distributed by: Mckesoon Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141

    Product of China

  • PRINCIPAL DISPLAY PANEL

    95898

  • INGREDIENTS AND APPEARANCE
    FOSTER AND THRIVE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1188-16 in 1 CARTON09/01/2023
    11 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2023
    Labeler - STRATEGIC SOURCING SERVICES, LLC (116956644)