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Oculoheel

Heel Inc

Oculoheel Eye Drops


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

Active ingredients: Each 0.45 ml vial contains: Cochlearia officinalis 5X, Echinacea 5X, Euphrasia officinalis 5X, Pilocarpus 5X

PURPOSE

Cochlearia officinalis 5X .........Relieves watery eyes
Echinacea 5X...........................Relieves watery eyes
Euphrasia officinalis 5X...........Relieves allergic eye symptoms
Pilocarpus 5X..........................Relieves tired eyes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OCULOHEEL INDICATIONS AND USAGE

For the temporary relief of minor eye symptoms associated with allergy or general strain:

  • Redness
  • Irritation
  • Watery Eyes

WARNINGS

In isolated cases, local allergic reactions such as redness or burning sensations may occur. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. If pregnant or breast feeding, ask a healthcare provider before use. Keep out of reach of children. If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to Oculoheel® or any of its ingredients exists.

OCULOHEEL DOSAGE AND ADMINISTRATION

Standard Dosage:

Adults and children 12 years and older: Instill 2 drops in the affected eye(s) every 6 hours.

Children 4 to 11 years: Instill 1 drop in the affected eye(s) every 6 hours.

For children under 4, consult your healthcare provider.

Initial Dosage:

Adults and children 12 years and older: Instill 2 drops in the affected eye(s) every 2 to 4 hours until symptoms lessen, then continue with standard dosage. Do not exceed 24 drops in 24 hours.

Children 4 to 11 years: Instill 1 drop in the affected eye(s) every 2 to 4 hours until symptoms lessen, then continue with standard dosage. Do not exceed 12 drops in 24 hours.

For children under 4, consult your healthcare provider.

Do not open the vial until just before use.

To open, twist and remove tab at the tip of the vial. Do not touch any surface with the tip of container. Instill contents in the affected eye. Tilt your head backward, hold the vial vertically pointing downward; allow drop(s) to drip from vial into the lower eye lid by slightly applying pressure onto the vial from above.

The vials are intended for one application. Discard any unused portion.

INACTIVE INGREDIENTS

Disodium phosphate dihydrate, Sodium dihydrogen phosphate dihydrate and Sterile isotonic saline solution.

Oculoheel

Oculoheel

COCHLEARIA OFFICINALIS FLOWERING TOP,ECHINACEA ANGUSTIFOLIA,EUPHRASIA STRICTA and PILOCARPUS JABORANDI LEAF SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50114-0114
Route of Administration INTRAOCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
COCHLEARIA OFFICINALIS FLOWERING TOP COCHLEARIA OFFICINALIS FLOWERING TOP 5 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 5 [hp_X]
EUPHRASIA STRICTA EUPHRASIA STRICTA 5 [hp_X]
PILOCARPUS JABORANDI LEAF PILOCARPUS JABORANDI LEAF 5 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE
sodium phosphate, dibasic, dihydrate
sodium phosphate, monobasic, dihydrate

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 0.45 in 1 VIAL, SINGLE-DOSE
2 NDC:50114-0114-2 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2005-06-27


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