Label: LIDOFLEX- lidoflex shoulder patch
LIDOFLEX ELBOW, SINGLE POUCH- lidoflex elbow patch
LIDOFLEX- lidoflex single pouch, back patch
LIDOFLEX- lidoflex single pouch, knee patch
LIDOFLEX- lidoflex heel patch
LIDOFLEX- lidoflex flex strip double patch

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    69313-632-01, 69313-632-05, 69313-632-20, 69313-633-01, view more
    69313-633-05, 69313-633-20, 69313-634-01, 69313-634-05, 69313-634-20, 69313-635-01, 69313-635-05, 69313-635-20, 69313-636-01, 69313-636-05, 69313-636-20, 69313-637-01, 69313-637-05, 69313-637-20
  • Packager: NAIMCO, INC. DBA RICHMAR, INC.
  • Category: HUMAN OTC DRUG LABEL

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 December 22, 2016

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

  • Primary Package Legal Copy and Artwork including active ingredients, inactive ingredients, instructions for use

    Primary Packaging

  • LIDOCAINE 4% PATCH

    4% LIDOCAINE PAIN RELIEVING PATCH
    4% LIDOCANIA PARCHE PARA ALIVIAR EL DOLOR
    4% LIDOCAÏNE TIMBRE DE SOULAGEMENT DE LA DOULEUR
    Drug Facts
    Active ingredient (in each patch) Purpose
    Lidocaine 4%...........................................................Topical anesthetic/analgesic/antipruritic

    Inactive ingredients
    Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive*, vanillyl butyl ether

    *adhesive not made with natural rubber latex.

  • LidoFLEX Secondary Packaging Commercial Display

    Heel 5 packElbow 5 packFlex 5 packShoulder 5 packBack 5 packKnee 5 packBack 20 packHeel 20 packElbow 20 packKnee 20 packShoulder 20 packFlex Strip 20 Pack

  • Warnings

    Do not apply over damaged, raw or blistered skin.
    Do not apply excessive quantity of patches within 24 hour period.
    Apply locally as needed; do not apply over large surface area of the body.
    Avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water. If condition worsens, or if symptoms persist for more than 7 days
    or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
    Do not use on the face or in large quantities, particularly over raw surfaces or blistered areas.
    Do not use with a heating pad.
    Stop use and ask a doctor if rash, itching or skin irritation develops.
    If pregnant or breast-feeding, ask a health professional before use.
    Keep out of the reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
    Package is not child-resistant.

  • DOSAGE & ADMINISTRATION

    Apply to affected area no more than three times per day.
    Apply patch to the affected area and leave in place for up to 8 but no more than 12 hours.

  • Inactive Ingredients

    Inactive ingredients
    Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive*, vanillyl butyl ether.

    *adhesive not made with natural rubber latex.

  • INDICATIONS & USAGE

    Use
    For the temporary relief of pain.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
    Package is not child-resistant.

  • LidoFLEX 4% Lidocaine Pain Relieving Patch

    4% LIDOCAINE PAIN RELIEVING PATCH4% LIDOCAINE PAIN RELIEVING PATCH4% LIDOCAINE PAIN RELIEVING PATCH4% LIDOCAINE PAIN RELIEVING PATCHCAUTIONS

    Apply to affected area no more than three (3) times per day.
    Apply patch to the affected area and leave in place for up to 8 but no more than 12 hours.
    DISCARDING USED PATCH
    Remove the patch and fold the adhesive sides together. Discard patch safely out of the reach of
    children and pets.
    Patent-Pending.
    4% LIDOCAINE PAIN RELIEVING PATCH
    4% LIDOCANIA PARCHE PARA ALIVIAR EL DOLOR
    4% LIDOCAÏNE TIMBRE DE SOULAGEMENT DE LA DOULEUR
    Drug Facts
    Active ingredient (in each patch) Purpose
    Lidocaine 4%...........................................................Topical anesthetic/analgesic/antipruritic
    Use
    For the temporary relief of pain.
    Warnings
    Do not apply over damaged, raw or blistered skin.
    Do not apply excessive quantity of patches within 24 hour period.
    Apply locally as needed; do not apply over large surface area of the body.
    Avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water. If condition worsens, or if symptoms persist for more than 7 days
    or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
    Do not use on the face or in large quantities, particularly over raw surfaces or blistered areas.
    Do not use with a heating pad.
    Stop use and ask a doctor if rash, itching or skin irritation develops.
    If pregnant or breast-feeding, ask a health professional before use.
    Keep out of the reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
    Package is not child-resistant.
    Directions
    Adults and children 12 years and older:
    For best results:
    • Remove excess hair at treatment site.
    • Clean area thoroughly with soap and water or alcohol wipe, removing all oils, lotions and dirt.
    • Do not use oils, lotions or powders in treatment area prior to application.
    • For best adhesion, apply as directed to the affected area a minimum of 1 hour prior to getting skin wet.
    • Open pouch and remove patch.
    • Remove protective liner and apply to skin.
    • Discard the liner.
    • Apply patch to the affected area, pressing down firmly from the center outwards to ensure adhesion and minimize folds.
    Continue to press down firmly until the patch has secure contact with the skin.
    • Apply to affected area no more than three (3) times per day.
    • Leave in place for up to 8 but no more than 12 hours.
    • For maximum pain relief, choose the appropriate size of patch based on the size of the treatment area and the body area to be treated.
    Example–use a LidoFlex back patch for back pain relief, use a LidoFlex Flex Strip for ankle or forearm pain relief.
    Patches may be cut into smaller sizes as needed to treat affected area. Before removing the clear protective liner, cut patch to the desired size. Once cut, remove the clear protective liner. Remaining patch material must be sealed to be effective. Discard all unused portions of the patch safely out of the reach of children and pets.
    Children under 12 years of age:
    Ask a doctor before use.
    Other information
    Some individuals may not experience pain relief until several hours after applying the patch.
    Store in a cool, dry place. Protect from freezing and excessive heat. Store at 68-77°F (20-25°C).
    Excursions permitted between 59 and 86°F (15 and 30°C).
    Use cleaning pads provided to remove any residual adhesive sticking to the skin.
    Inactive ingredients
    Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive*, vanillyl butyl ether.
    *adhesive not made with natural rubber latex.

    Package not child-resistant. Keep out of the reach of children.
    To report SUSPECTED ADVERSE REACTIONS, contact Richmar Regulatory at 1.888.549.4945 or 1.423.648.7730 www.lidoflex.comHeel 5 pkElbow 5 pkFlex 5 pkShoulder 5 pkBack 5 pkKnee 5 pk

  • INGREDIENTS AND APPEARANCE
    LIDOFLEX 
    lidoflex shoulder patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69313-636
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE25.3 mg  in 0.24 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69313-636-0525.3 mg in 1 BAG; Type 0: Not a Combination Product10/01/2014
    2NDC:69313-636-0125.3 mg in 1 POUCH; Type 0: Not a Combination Product10/01/2014
    3NDC:69313-636-2025.3 mg in 1 PACKAGE; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2014
    LIDOFLEX  ELBOW, SINGLE POUCH
    lidoflex elbow patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69313-633
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE21.5 mg  in 0.24 mg
    Inactive Ingredients
    Ingredient NameStrength
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    CROSPOVIDONE (UNII: 68401960MK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69313-633-0121.5 mg in 1 POUCH; Type 0: Not a Combination Product10/01/2014
    2NDC:69313-633-0521.5 mg in 1 BAG; Type 0: Not a Combination Product10/01/2014
    3NDC:69313-633-2021.5 mg in 1 PACKAGE; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2014
    LIDOFLEX 
    lidoflex single pouch, back patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69313-632
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE29 mg  in 0.24 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69313-632-0129 mg in 1 POUCH; Type 0: Not a Combination Product10/01/2014
    2NDC:69313-632-0529 mg in 1 BAG; Type 0: Not a Combination Product10/01/2014
    3NDC:69313-632-2029 mg in 1 PACKAGE; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2014
    LIDOFLEX 
    lidoflex single pouch, knee patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69313-635
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE25.8 mg  in 0.24 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69313-635-0125.8 mg in 1 POUCH; Type 0: Not a Combination Product10/01/2014
    2NDC:69313-635-0525.8 mg in 1 BAG; Type 0: Not a Combination Product10/01/2014
    3NDC:69313-635-2025.8 mg in 1 PACKAGE; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2014
    LIDOFLEX 
    lidoflex heel patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69313-634
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE22.7 mg  in 0.24 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69313-634-0122.7 mg in 1 POUCH; Type 0: Not a Combination Product10/01/2014
    2NDC:69313-634-0522.7 mg in 1 BAG; Type 0: Not a Combination Product10/01/2014
    3NDC:69313-634-2022.7 mg in 1 PACKAGE; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2014
    LIDOFLEX 
    lidoflex flex strip double patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69313-637
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE28.1 mg  in 0.24 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69313-637-0128.1 mg in 1 POUCH; Type 0: Not a Combination Product10/01/2014
    2NDC:69313-637-0528.1 mg in 1 BAG; Type 0: Not a Combination Product10/01/2014
    3NDC:69313-637-2028.1 mg in 1 PACKAGE; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2014
    Labeler - NAIMCO, INC. DBA RICHMAR, INC. (959353152)
    Registrant - NAIMCO, INC. DBA RICHMAR, INC. (959353152)
    Establishment
    NameAddressID/FEIBusiness Operations
    Naimco, INC959353152manufacture(69313-633, 69313-632, 69313-635, 69313-636, 69313-634, 69313-637)