Limencin Patch

Manufacturer
Alexso Inc.
Effective date
2019-02-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:58:33

Label at a glance#

ProductLimencin
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Dosage and administration

Adults and children 12 years and over: Apply patch to affected area 1 to 2 times daily or as directed. Instruction for Use: ▪ Clean and dry the affected area ▪ Open pouch and remove one patch ▪ Remove any protective film and apply directly to affected area of pain ▪ Wash hands with soap and water after applying patch ▪ Reseal pouch containing unused patches after each use

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Warnings:

WARNINGS SECTION

  • Only for external use. Use only as directed or by a health professional.
  • Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucus membranes.
  • Do not cover with bandage.
  • Keep out of reach of children. Consult physician for children under 12.
  • Consult your physician: if pregnant or pain persists or worsens.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over: Apply patch to affected area 1 to 2 times daily or as directed.

Instruction for Use:

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Remove any protective film and apply directly to affected area of pain
  • Wash hands with soap and water after applying patch
  • Reseal pouch containing unused patches after each use

Other Ingredients:

INACTIVE INGREDIENT SECTION

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Citrus Medica Limonum (Lemon) Peel Oil, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcarbamate, Propylparaben.

Patient Medication Information

PATIENT MEDICATION INFORMATION SECTION

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image-01

This topical pain relief patch was recently reformulated by pharmacists who specialize in pain management. Natural ingredients have been added to these patches for a better, more refreshing scent. Scientific studies have shown that both ingredients used in this product significantly reduce pain and inflammation.i A combination of ingredients with analgesics and anesthetic properties are used in a unique way to maximize its pain relieving effects and to aid in addition to other therapies. This offers long lasting relief for a variety of pain conditions. Limencin Patch is manufactured in accordance with FDA regulations by an FDA approved manufacturer.

Mechanism of Action:

SPL UNCLASSIFIED SECTION

Menthol has some local anesthetic and counterirritant qualities and also acts as a weak kappa opioid receptor agonist making it an analgesic as well. Its ability to chemically trigger the cold-sensitive TRPM8 receptors in the skin is responsible for its cooling sensation when applied to the skin. Lastly, it enhances the efficacy of other topical applications by increasing penetration via vasodilation.

Lidocaine is a common local anesthetic that relieves itching, burning, and pain. Topically, it blocks both initiation and conduction of nerve impulses by decreasing ionic flux through the neuronal membrane. Since it penetrates the skin, it creates an anesthetic effect by not just preventing pain signals from propagating to the brain, but by stopping them before they begin.

Benefits:

SPL UNCLASSIFIED SECTION

The use of this topical medication, Limencin Patch, over other oral options for pain relief can benefit patients in many different ways. Conventional therapies using opioids (hydrocodone, hydromorphone, morphine, oxycodone) can cause systemic adverse effects such as constipation, drowsiness, dizziness, lightheadedness, nausea, vomiting, sedation, and/or confusion. NSAIDs (ibuprofen, naproxen) can increase cardiovascular risk, decrease platelet aggregation, and cause gastrointestinal bleeding or ulcers. Other classes of medications such as antidepressants (nortriptyline, duloxetine) or anticonvulsants (gabapentin) also come with its costs and side effects. Limencin Patch acts only locally since it penetrates the skin and not into the bloodstream. In addition, patients can have one or multiple disease states including renal or hepatic dysfunction which can prevent them from taking ibuprofen (Advil) or acetaminophen (Tylenol) respectively. More importantly, this patch gives physicians an option to provide effective pain relief treatment while avoiding the addictive properties of conventional oral medications. It can also be supplemented with other topical pain lotions. In addition, it avoids messy application and reduces risk of getting ingredients in eyes or other mucous membranes.

Product Information and Data:

SPL UNCLASSIFIED SECTION

Pharmacists that have been in the field of pain management for many years used research from all parts of the world to carefully formulate this patch in order to maximize its pain relieving properties.iii Skin penetrating mixtures have also been added to enhance rapid absorption of the active ingredients through the skin to allow deeper penetration into the muscles, joints, and nerves. Lidocaine patches for therapy of neuropathic and non-neuropathic pain was concluded “to be an effective and safe option for add-on therapy” (Nervenarzt, 2010) in a clinical case series using 87 patients.iv Another study in 2010 concluded that a single 8 hour application of a combination patch of menthol provided signigicant pain relief associated with mild to moderate strains when compared to a placebo patch.v The use of these pharmaceutical and natural components provides more pain relief and makes the patch a new way to address pain. These ingredients comply with The Chronic Pain Medical Treatment Guidelines and the ACOEM guidelines for pain management.vi Page 111 of the Chronic Pain Medical Treatment Guidelines concludes that topical analgesics are “primarily recommended for neuropathic pain when trials of antidepressants and anticonvulsants have failed (Namaka, 2004).” In addition to this, “these agents are applied locally to painful areas with advantages that include lack of systemic side effects, absence of drug interactions, and no need to titrate (Colombo, 2006).” This product is “recognized as safe and effective” because it meets all conditions of the CFR.vii Limencin Patch complies with The Chronic Pain Medical Treatment Guidelines and the ACOEM guidelines for a variety of pains mentioned above.viii

Adverse Reactions

ADVERSE REACTIONS SECTION

Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging. Please be aware of any unpleasant side effects as described. If any of these effects persists or worsens, contact your physician or pharmacist immediately. This medication is not absorbed systemically but if any serious side effects (i.e. rash, itching/swelling, severe dizziness) are experienced, discontinue use immediately and contact your pharmacist or physician. This is not a complete list of all side effects that may occur. You may report side effects to the FDA at 800-FDA-1088 or at www.fda.gov/medwatch

Warnings and Precautions

WARNINGS AND PRECAUTIONS SECTION

• For external use only. Use only as directed or by a health professional.

• Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucus membranes.

•Do not cover with bandage.

•Consult your physician: if pregnant or if pain persists and/or worsens

•Consult your physician: if pain persists or worsens or if using any other topical pain products.

• Store in a dry, cool place

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Consult physician for children under 12 years.

Overdosage

OVERDOSAGE SECTION

In Case of Ingestion or Overdose, get medical help or contact a Poison Control Center (800-222-1222) right away.

References

SPL UNCLASSIFIED SECTION

  1. Dunteman E. Targeted peripheral analgesics in Chronic Pain Syndromes. Practical Pain Management 2005; July/August: 14-25
  2. Jones M. Chronic neuropathic pain: Pharmacologic interventions in the new millennium. A theory of efficacy. International J Pharmaceutical Compounding. 2004(1):6-15.
  3. Baron R, Mahn F. Types of topical treatment for peripheral neuropathic pain: Mechanism of action and indications. Schmerz 2010;24(4):317-25.
  4. Kern KU, Kohl M, Kiefer RT. Lidocaine patch for therapy of neuropathic and non-neuropathic pain. A clinical case series of 87 patients. Nervenarzt 2010 Dec;81(12): 1490-7
  5. Higashi Y, Kiuchi T, Furuta K. Efficacy and safety profile of a topical methyl salicylate and menthol patch in adult patients with mild to moderate muscle strain: a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. Clinical Therapeutics. 2010 Jan;32(1): 34-43.
  6. ACOEM. Occupational Medicine Practice Guidelines, 2nd Edition. American College of Occupational and Environmental Medicine, 25 Northwest Point Blvd., Suite 700, Elk Grove Village, Illinois, 60007-1030 (www.acoem.org.). 2004:116.
  7. CFR – Code of Federal Regulations. Food and Drug Administration. Chapter 1: Part 346. Revised April 1, 2010.
  8. Chronic Pain Medical Treatment Guidelines, Medical Treatment Utilization Schedule (MTUS). Effective July 18, 2009.

Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image-02
image-02

Limencin Patch

Topical Pain Patch
for long lasting relief

NDC 50488-1201-1

Qty: 10 Articulated Patches
(5 per Resealable Pouch) x 2

Manufactured for:

Alexso, Inc.
2317 Cotner Avenue
Los Angeles, CA 90064
www.alexso.com
888-495-6078

Store in a dry, cool place

For Comments or Questions, call 888-495-6078

Patent Pending

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1428948lidocaine 4 % / menthol 4 % Medicated PatchPSN4
1428948lidocaine 0.04 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD4
1428948lidocaine 4 % / menthol 4 % Medicated PatchSY4

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
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
50488-1201-12024-01-30C16284748780-11030e365-3d96-111a-e063-dadaa90a10e2Limencin Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1201-1Limencin5 in 1 POUCHPATCH54
50488-1201-1Limencin2 in 1 CARTONPATCH24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1201LIMENCIN (LIDOCAINE AND MENTHOL) PATCH [ALEXSO INC.]4Legacy NDC, 2 package rows20190215_3f541c7c-e6d6-47cb-8406-865bc61f8c5d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1201-1EA - Each50488-12015463783d-e35e-4348-8bac-7f690345889d12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009872
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
LIDOCAINEACTIVE MOIETY98PI2009872
MENTHOLACTIVE MOIETYL7T10EIP3A2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW42
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB2
LEMON PEELINACTIVE INGREDIENT72O054U6282
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341L2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50488-120150488-1201-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 380 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, CHEWABLE / ORAL0.14 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / NASAL14 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HENEMA / RECTAL0.01 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
78 equally ranked IID candidates

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
59f67b29-7a6c-4420-ad1a-8f1ae1eac36e3f541c7c-e6d6-47cb-8406-865bc61f8c5d2019-02-12Warnings, Adverse reactionsExact identifier
spl id: 59f67b29-7a6c-4420-ad1a-8f1ae1eac36e
spl set id: 3f541c7c-e6d6-47cb-8406-865bc61f8c5d

Reported adverse events (FAERS/openFDA)#

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