OcuMend

Manufacturer
Cearna, Inc. | Katecho, Inc.
Effective date
2012-03-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:03:46

Label at a glance#

ProductOcuMend
Active ingredientARNICA MONTANA, LEDUM PALUSTRE TWIG
Label structure14 sections

Storage and handling

Other information for Vial: Store at room temperature.  Discard 30 days after opening. Other information for Healing Gels: Store at room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients for Vial:

Arnica Montana 52M 50% HPUS

Ledum Palustre 52M 50% HPUS


Active Ingredients for Healing Gels:

Arnica Montana 52M 50% HPUS

Ledum Palustre 52M 50% HPUS


OTC - PURPOSE SECTION

Purpose for Vial:

Arnica Montana 52M 50% HPUS .................................... Bruising

Ledum Palustre 52M 50% HPUS ..................................Black Eye

Purpose for Healing Gels:

Arnica Montana 52M 50% HPUS .................................... Bruising

Ledum Palustre 52M 50% HPUS ..................................Black Eye

INDICATIONS & USAGE SECTION

Uses for Vial:

For the reduction of bruising, swelling and pain.

Uses for Healing Gels:

For the reduction of bruising, swelling and pain.

WARNINGS SECTION

Warnings for Vial:

For external use only

Warnings for Healing Gels:

For external use only

OTC - DO NOT USE SECTION

Do not use for Vial:

Do not use

  • in the eyes
  • if solution becomes cloudy
  • if tamper seal is broken
Do not use for Healing Gels:

Do not use

  • in the eyes
  • over open wounds
  • if you have unexpected bleeding

OTC - STOP USE SECTION

Stop use for Vial:

Stop use and ask a doctor if condition worsens.

Stop use for Healing Gels:

Stop use and ask a doctor if condition worsens.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy Warning for Vial:

If pre gnant or breast-feeding ask a health professional before use.

Pregnancy Warning for Healing Gels:

If pre gnant or breast-feeding ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children Section for Vial:

Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Children Section for Healing Gels:

Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions for Vial:

Use as directed by a physician.  Pour contents of vial into sterile water.  Soak sterile gauze in water mixture and apply to affected site.

Directions for Healing Gels:

Use as directed by a physician.  Place healing gels on intact skin and replace as needed.

STORAGE AND HANDLING SECTION

Other information for Vial:

Store at room temperature.  Discard 30 days after opening.

Other information for Healing Gels:

Store at room temperature.

INACTIVE INGREDIENT SECTION

Inactive Ingredients (non-preserved) for Vial:

Citrates, Polysorbate 80, Sodium Chloride, Sterile Water

Inactive Ingredients for Healing Gels:

Acrylates/Acrylamide Co-polymer, Hydroxyethyl Cellulose, Methyldiethanolamine, Water

OTC - QUESTIONS SECTION

Questions for Vial:

Call 1-855-223-2762 or Email info@cearna.com

Questions for Healing Gels:

Call 1-855-223-2762 or Email info@cearna.com

DESCRIPTION SECTION

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

Do not use if box seal is broken or missing, if peel pouches are open or if band on vial is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OcuMend Principal Display Panel
OcuMend Principal Display Panel

OcuMend Drug Facts
OcuMend Drug Facts

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76277-211-612019-11-13C16284748780-197449f38-cbff-f6ea-e053-dbdaa90aa703d2e9076c-bbbd-408a-a80e-de1dd1b0b73a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76277-211-61OcuMend1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76277-211OCUMEND (ARNICA MONTANA, LEDUM PALUSTRE) KIT [CEARNA, INC.]2Legacy NDC, 1 package rows20120517_d2e9076c-bbbd-408a-a80e-de1dd1b0b73a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW2
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0P2
ARNICA MONTANAACTIVE MOIETYO80TY208ZW2
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0P2
METHYL DIETHANOLAMINEINACTIVE INGREDIENT3IG3K131QJ2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76277-21176277-211-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 4 · 212 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / TOPICAL0.98 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / EPIDURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INFILTRATION648 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HDROPS / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, DENTIFRICE / DENTAL0.03 mg/mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAMUSCULAR4 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RESPIRATORY (INHALATION)108 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / ENDOTRACHEAL7.6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATUMOR1.2 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / OPHTHALMIC10 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVENOUS0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / SUBMUCOSAL17 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL34 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAVITARY0.82 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / VAGINAL0.4 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HDROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER / ORAL66 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / RECTAL72.15 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SOLUTION / OPHTHALMIC0.9 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL11 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR24 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRATHECAL131 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAVENOUS1170 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / OPHTHALMIC3 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY / NASAL30 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACARDIAC70 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / VAGINAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 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
28f09ade-a67b-4c93-a857-7aece06b3ee6d2e9076c-bbbd-408a-a80e-de1dd1b0b73a2012-03-08WarningsExact identifier
spl id: 28f09ade-a67b-4c93-a857-7aece06b3ee6
spl set id: d2e9076c-bbbd-408a-a80e-de1dd1b0b73a

Reported adverse events (FAERS/openFDA)#

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