OCUMEND - arnica montana, ledum palustre 
Cearna, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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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


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

Uses for Vial:

For the reduction of bruising, swelling and pain.

Uses for Healing Gels:

For the reduction of bruising, swelling and pain.

Warnings for Vial:

For external use only

Warnings for Healing Gels:

For external use only


Do not use for Vial:

Do not use

Do not use for Healing Gels:

Do not use

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.

Pregnancy Warning for Vial:

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

Pregnancy Warning for Healing Gels:

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

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.

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.

Other information for Vial:

Store at room temperature.  Discard 30 days after opening.

Other information for Healing Gels:

Store at room temperature.

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

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



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.

OcuMend Principal Display Panel

OcuMend Drug Facts


OCUMEND 
arnica montana, ledum palustre kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76277-211
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76277-211-611 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKAGE 17 
Part 21 VIAL 15 mL
Part 1 of 2
OCUMEND  HEALING TWO PACKS
arnica montana, ledum palustre gel
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA52 [hp_M]
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG52 [hp_M]
Inactive Ingredients
Ingredient NameStrength
METHYL DIETHANOLAMINE (UNII: 3IG3K131QJ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
117 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2012
Part 2 of 2
OCUMEND  STERILE VIAL
arnica montana, ledum palustre liquid
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA52 [hp_M]  in 15 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG52 [hp_M]  in 15 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
115 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2012
Labeler - Cearna, Inc. (968104609)
Registrant - Cearna, Inc. (968104609)
Establishment
NameAddressID/FEIBusiness Operations
Katecho, Inc.139791743manufacture

Revised: 3/2012
Document Id: 28f09ade-a67b-4c93-a857-7aece06b3ee6
Set id: d2e9076c-bbbd-408a-a80e-de1dd1b0b73a
Version: 2
Effective Time: 20120308
 
Cearna, Inc.