SPL v2
SPL
SPL Set ID 2b5fc4c4-843c-8d3d-e063-6394a90a5a1b
Route
OPHTHALMIC
Published
Effective Date 2018-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypromellose 2910 (4000 Mpa.s) (3 mg)
Inactive Ingredients
Potassium Chloride Sodium Phosphate Dibasic Dihydrate Benzyl Alcohol Water Sodium Hyaluronate Sodium Chloride Sodium Phosphate, Monobasic, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-12

Description

Instill one or two drops in the affected eye(s) as needed.


Medication Information

Warnings and Precautions

For external use only.

If you are pregnant, nursing, trying to conceive, taking any medications, or have a medical condition, please consult your healthcare practitioner before using this product.

Stop use and ask a doctor 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.

Do not use if solution changes color or becomes cloudy.

If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Description

Instill one or two drops in the affected eye(s) as needed.

Section 51727-6

Inactive Ingredients:

Water, sodium chloride, sodium hyaluron-ate, potassium chloride, sodium phosphate dibasic, sodium phosphate monobasic, benzyl alcohol.

Section 55105-1

Purpose: Lubricant

Section 55106-9

Hypromellose 0.3% Lubricant

Directions

Instill one or two drops in the affected eye(s) as needed.

Keep Out of Reach

Keep out of reach of children

Inidication and Use

For the temporary relief of burning, irritaiton and discomofrt due to drynes of the eye or exposure to wind and sun,. May be uysed as a protectant against further irritation

Principal Display Panel


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

If you are pregnant, nursing, trying to conceive, taking any medications, or have a medical condition, please consult your healthcare practitioner before using this product.

Stop use and ask a doctor 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.

Do not use if solution changes color or becomes cloudy.

If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, sodium chloride, sodium hyaluron-ate, potassium chloride, sodium phosphate dibasic, sodium phosphate monobasic, benzyl alcohol.

Section 55105-1 (55105-1)

Purpose: Lubricant

Section 55106-9 (55106-9)

Hypromellose 0.3% Lubricant

Directions

Instill one or two drops in the affected eye(s) as needed.

Keep Out of Reach (Keep out of Reach)

Keep out of reach of children

Inidication and Use

For the temporary relief of burning, irritaiton and discomofrt due to drynes of the eye or exposure to wind and sun,. May be uysed as a protectant against further irritation

Principal Display Panel (Principal display panel)


Advanced Ingredient Data


Raw Label Data

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