SPL v6
SPL
SPL Set ID 174193b2-65eb-b5fd-e063-6394a90a9cd0
Route
OPHTHALMIC
Published
Effective Date 2024-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (2.5 mg)
Inactive Ingredients
Levocarnitine Hyaluronate Sodium Sodium Chloride Calcium Chloride Boric Acid Sodium Borate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-29

Description

Glycerin 0.25%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye or to the exposure to wind or sun
  • for use as a protectant against further irritation or to temporarily relieve dryness of the eye

Dosage and Administration

Glycerin 0.25%

Instill 1 or 2 drops in the affected eye(s) as needed

Description

Glycerin 0.25%

Section 44425-7
  • Store at 15-25ºC (55-77ºF)
  • LOT number and expiration date on bottom of box and bottle
Section 50565-1
  • if swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9

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
Section 50567-7
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use
Section 50570-1
  • if solution changes color or becomes cloudy
  • if tamper evident ring is broken or missing
Section 51727-6

borate, boric acid, sodium chloride, calcium chloride, l-carnitine, sodium hyluronate

Section 51945-4

VIVA

dry eye therapy

hydration

lubricating eye drops

instant, moisture for dry, irritated eyes

Preservative-Free

For irritated, dry eyes

pH Balanced for comfort

See inside leaflet for additional information and how to use

Sterile .33 fl oz (10mL)

Preservative-Free Multi-Dose Bottle

Section 53413-1

Amcon Laboratories, Inc.

St. Louis, MO 63123

1.800.255.6161

email:

[email protected]

Section 55105-1

Lubricant

Section 55106-9

Glycerin 0.25%

Section 59845-8
  • instill 1 or 2 drops in the affected eye(s) as needed

Structured Label Content

Indications and Usage (34067-9)
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye or to the exposure to wind or sun
  • for use as a protectant against further irritation or to temporarily relieve dryness of the eye

Dosage and Administration (34068-7)

Glycerin 0.25%

Instill 1 or 2 drops in the affected eye(s) as needed

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)
  • Store at 15-25ºC (55-77ºF)
  • LOT number and expiration date on bottom of box and bottle
Section 50565-1 (50565-1)
  • if swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use
Section 50570-1 (50570-1)
  • if solution changes color or becomes cloudy
  • if tamper evident ring is broken or missing
Section 51727-6 (51727-6)

borate, boric acid, sodium chloride, calcium chloride, l-carnitine, sodium hyluronate

Section 51945-4 (51945-4)

VIVA

dry eye therapy

hydration

lubricating eye drops

instant, moisture for dry, irritated eyes

Preservative-Free

For irritated, dry eyes

pH Balanced for comfort

See inside leaflet for additional information and how to use

Sterile .33 fl oz (10mL)

Preservative-Free Multi-Dose Bottle

Section 53413-1 (53413-1)

Amcon Laboratories, Inc.

St. Louis, MO 63123

1.800.255.6161

email:

[email protected]

Section 55105-1 (55105-1)

Lubricant

Section 55106-9 (55106-9)

Glycerin 0.25%

Section 59845-8 (59845-8)
  • instill 1 or 2 drops in the affected eye(s) as needed

Advanced Ingredient Data


Raw Label Data

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