OCUMEND- arnica montana, ledum palustre kit

OcuMend by

Drug Labeling and Warnings

OcuMend by is a Homeopathic medication manufactured, distributed, or labeled by Cearna, Inc., Katecho, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

Uses for Vial:

For the reduction of bruising, swelling and pain.

Uses for Healing Gels:

For the reduction of bruising, swelling and pain.

WARNINGS

Warnings for Vial:

For external use only

Warnings for Healing Gels:

For external use only

DO NOT USE

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
  

STOP 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 OR BREAST FEEDING

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.

KEEP OUT OF REACH OF CHILDREN

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

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

Other information for Vial:

Store at room temperature.  Discard 30 days after opening.

Other information for Healing Gels:

Store at room temperature.

INACTIVE INGREDIENT

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

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OCUMEND 
arnica montana, ledum palustre kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76277-211

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76277-211-61	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKAGE	17
Part 2	1 VIAL	15 mL

Part 1 of 2

OCUMEND  HEALING TWO PACKS
arnica montana, ledum palustre gel

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	52 [hp_M]
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	52 [hp_M]

Inactive Ingredients
Ingredient Name	Strength
METHYL DIETHANOLAMINE (UNII: 3IG3K131QJ)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		17 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/17/2012

Part 2 of 2

OCUMEND  STERILE VIAL
arnica montana, ledum palustre liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	52 [hp_M]  in 15 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	52 [hp_M]  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/17/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/17/2012

Labeler - Cearna, Inc. (968104609)

Registrant - Cearna, Inc. (968104609)

Establishment
Name	Address	ID/FEI	Business Operations
Katecho, Inc.		139791743	manufacture