Olu Pain Management Patch

Manufacturer
Olakino Therapeutics LLC
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:42

Label at a glance#

ProductOlu Pain Management
Active ingredientCAMPHOR (NATURAL), LIDOCAINE
Label structure18 sections

Indications and uses

For the temporary relief of muscle pain and joint pain associated with: -Backache -Cramps -Soreness -Strains -Discomfort -Neckache

Dosage and administration

Adults and Children 12 Years of Age and Older: -Clean and dry the affected area -Apply gel pad directly onto skin for up to 12 hours -Wash hands immediately after use -Gel pad can be cut into pieces and used on up to 2 body parts at a time -One application per day is recommended

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

PURPOSE

OTC - PURPOSE SECTION

Local Anesthetic

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Camphor 1%

PURPOSE

OTC - PURPOSE SECTION

Counterirritant

USES

INDICATIONS & USAGE SECTION

For the temporary relief of muscle pain and joint pain associated with:

-Backache -Cramps -Soreness -Strains -Discomfort -Neckache

WARNINGS:

WARNINGS SECTION

FOR EXTERNAL USE ONLY

ALLERGY ALERT

SPL UNCLASSIFIED SECTION

Local anesthetics may cause methemoglobinemia. If an allergic reaction occurs, stop use and seek medical attention immediately.

DO NOT USE

OTC - DO NOT USE SECTION

-On damaged, irritated, or infected skin

-With a bandage or heating pad

-If you are allergic to any ingredients in this product

-In the eyes, nose, or mouth

-Otherwise as directed

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

Avoid contact with the eyes, nose, and mouth

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

-Any of the warnings apply to you

-Excessive skin irritation develops

-Condition worsens

-Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

IF PREGNANT OR BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a healthcare professional before use

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, seek medical help or contact Poison Control immediately

FLAMMABLE

SPL UNCLASSIFIED SECTION

Keep away from excessive heat or open flame

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 Years of Age and Older:

-Clean and dry the affected area

-Apply gel pad directly onto skin for up to 12 hours

-Wash hands immediately after use

-Gel pad can be cut into pieces and used on up to 2 body parts at a time

-One application per day is recommended

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

-Store in a cool, dry place with pouch tightly closed. Keep from freezing.

-If the tamper-evident foil seal is not intact, do not use

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Arnica Extract, Boswellia Extract, Vitamin C, Vitamin E, Ethyl Alcohol, Propylene Glycol, Glycerol, Sodium Polyacrylate, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Water

QUESTIONS OR COMMENTS

SPL UNCLASSIFIED SECTION

info@olakinotherapeutics.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pouchpouch

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2700664camphor 1 % / lidocaine 4 % Medicated PatchPSN2
2700664camphor 0.01 MG/MG / lidocaine 0.04 MG/MG Medicated PatchSCD2
2700664camphor 1 % / lidocaine 4 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

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

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84991-0208-1Olu Pain Management5 in 1 POUCHPATCH52
84991-0208-1Olu Pain Management3 in 1 BOXPATCH32
84991-0208-5Olu Pain Management5 in 1 POUCHPATCH52
84991-0208-5Olu Pain Management8.5 g in 1 PATCHPATCH8.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84991-0208OLU PAIN MANAGEMENT (LIDOCAINE AND CAMPHOR) PATCH [OLAKINO THERAPEUTICS LLC]2Current NDC, 4 package rows20250210_2a41a621-c6f7-5819-e063-6394a90ae67d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84991-0208-1EA - Each84991-020814a60efa-e657-494d-8cae-20f4205b279612025-03-04

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84991-020884991-0208-1, 84991-0208-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
Olu Pain ManagementLIDOCAINE AND CAMPHOROlakino Therapeutics LLC2a41a621-c6f7-5819-e063-6394a90ae67d2025-02-07WarningsExact identifier
ndc (package): 84991-0208-1
ndc (package): 84991-0208-5
ndc (product): 84991-0208
ndc11 (package): 84991020805
ndc11 (package): 84991020801
spl id: 2d94d820-91eb-3b5e-e063-6394a90a1a42
spl set id: 2a41a621-c6f7-5819-e063-6394a90ae67d

Reported adverse events (FAERS/openFDA)#

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