LidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products

Manufacturer
NAIMCO, INC. DBA RICHMAR, INC. | Naimco, INC
Effective date
2016-12-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:48:14

Label at a glance#

ProductLidoFLEX
Active ingredientLIDOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

LIDOCAINE 4% PATCH

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

Warnings

WARNINGS SECTION

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 SECTION

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 INGREDIENT SECTION

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 SECTION

Use
For the temporary relief of pain.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% LIDOCAINE PAIN RELIEVING PATCH4% LIDOCAINE PAIN RELIEVING PATCH4% LIDOCAINE PAIN RELIEVING PATCH4% LIDOCAINE PAIN RELIEVING PATCH4% 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.com Heel 5 pkHeel 5 pk Elbow 5 pkElbow 5 pk Flex 5 pkFlex 5 pk Shoulder 5 pkShoulder 5 pk Back 5 pkBack 5 pk Knee 5 pkKnee 5 pk

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369313632057GTIN-13: 0369313632057
EAN-13: 0369313632057
GTIN-12: 369313632057
UPC-A: 369313632057
GTIN storage (14 digits): 00369313632057
3033.15.12.A LidoFlex 5pk Back.jpg
BarcodeEAN-130369313633054GTIN-13: 0369313633054
EAN-13: 0369313633054
GTIN-12: 369313633054
UPC-A: 369313633054
GTIN storage (14 digits): 00369313633054
3034.15.12.A LidoFlex 5pk Elbow.jpg
BarcodeEAN-130369313634051GTIN-13: 0369313634051
EAN-13: 0369313634051
GTIN-12: 369313634051
UPC-A: 369313634051
GTIN storage (14 digits): 00369313634051
3036.15.12.A LidoFlex 5pk Heel.jpg
BarcodeEAN-130369313635058GTIN-13: 0369313635058
EAN-13: 0369313635058
GTIN-12: 369313635058
UPC-A: 369313635058
GTIN storage (14 digits): 00369313635058
3037.15.12.A LidoFlex 5pk Knee.jpg
BarcodeEAN-130369313636055GTIN-13: 0369313636055
EAN-13: 0369313636055
GTIN-12: 369313636055
UPC-A: 369313636055
GTIN storage (14 digits): 00369313636055
3038.15.12.A LidoFlex 5pk Shoulder.jpg
BarcodeEAN-130369313637052GTIN-13: 0369313637052
EAN-13: 0369313637052
GTIN-12: 369313637052
UPC-A: 369313637052
GTIN storage (14 digits): 00369313637052
3035.15.12.A LidoFlex 5pk Flex.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69313-632-012020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-632-052020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-632-202020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-633-012020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-633-052020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-633-202020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-634-012020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-634-052020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-634-202020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-635-012020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-635-052020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-635-202020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-636-012020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-636-052020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-636-202020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-637-012020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-637-052020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products
69313-637-202020-01-31C16284748780-19d75b9cf-ed4a-f424-e053-dadaa90a57ceLidoFLEX Analgesic/Anesthetic/Antipruritic Patch Products

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69313-632-01LidoFLEX29 mg in 1 POUCHPATCH294
69313-632-05LidoFLEX29 mg in 1 BAGPATCH294
69313-632-20LidoFLEX29 mg in 1 PACKAGEPATCH294
69313-633-01LidoFLEXElbow, Single Pouch21.5 mg in 1 POUCHPATCH21.54
69313-633-05LidoFLEXElbow, Single Pouch21.5 mg in 1 BAGPATCH21.54
69313-633-20LidoFLEXElbow, Single Pouch21.5 mg in 1 PACKAGEPATCH21.54
69313-634-01LidoFLEX22.7 mg in 1 POUCHPATCH22.74
69313-634-05LidoFLEX22.7 mg in 1 BAGPATCH22.74
69313-634-20LidoFLEX22.7 mg in 1 PACKAGEPATCH22.74
69313-635-01LidoFLEX25.8 mg in 1 POUCHPATCH25.84
69313-635-05LidoFLEX25.8 mg in 1 BAGPATCH25.84
69313-635-20LidoFLEX25.8 mg in 1 PACKAGEPATCH25.84
69313-636-01LidoFLEX25.3 mg in 1 POUCHPATCH25.34
69313-636-05LidoFLEX25.3 mg in 1 BAGPATCH25.34
69313-636-20LidoFLEX25.3 mg in 1 PACKAGEPATCH25.34
69313-637-01LidoFLEX28.1 mg in 1 POUCHPATCH28.14
69313-637-05LidoFLEX28.1 mg in 1 BAGPATCH28.14
69313-637-20LidoFLEX28.1 mg in 1 PACKAGEPATCH28.14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69313-632LIDOFLEX (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 [NAIMCO, INC. DBA RICHMAR, INC.]4Legacy NDC, 3 package rows20161222_06041bf8-07d7-3a70-e054-00144ff8d46c.zip
69313-633LIDOFLEX (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 [NAIMCO, INC. DBA RICHMAR, INC.]4Legacy NDC, 3 package rows20161222_06041bf8-07d7-3a70-e054-00144ff8d46c.zip
69313-634LIDOFLEX (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 [NAIMCO, INC. DBA RICHMAR, INC.]4Legacy NDC, 3 package rows20161222_06041bf8-07d7-3a70-e054-00144ff8d46c.zip
69313-635LIDOFLEX (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 [NAIMCO, INC. DBA RICHMAR, INC.]4Legacy NDC, 3 package rows20161222_06041bf8-07d7-3a70-e054-00144ff8d46c.zip
69313-636LIDOFLEX (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 [NAIMCO, INC. DBA RICHMAR, INC.]4Legacy NDC, 3 package rows20161222_06041bf8-07d7-3a70-e054-00144ff8d46c.zip
69313-637LIDOFLEX (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 [NAIMCO, INC. DBA RICHMAR, INC.]4Legacy NDC, 3 package rows20161222_06041bf8-07d7-3a70-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009872
LIDOCAINEACTIVE MOIETY98PI2009872
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLINACTIVE INGREDIENTKD6TZ2QICH2
CROSPOVIDONEINACTIVE INGREDIENT68401960MK2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
444511c6-ef0b-2d22-e054-00144ff8d46c06041bf8-07d7-3a70-e054-00144ff8d46c2016-12-22WarningsExact identifier
spl id: 444511c6-ef0b-2d22-e054-00144ff8d46c
spl set id: 06041bf8-07d7-3a70-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.