SPL v7
SPL
SPL Set ID f27a6799-e2f1-ee8d-e053-2a95a90aead1
Route
OPHTHALMIC
Published
Effective Date 2022-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypromellose 2208 (15000 Mpa.s) (20 mg)
Inactive Ingredients
Sodium Citrate Sodium Acetate Potassium Chloride Water Sodium Chloride Magnesium Chloride Calcium Chloride Citric Acid Acetate Acetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-09-26 Until 2027-12-31
Description

Hypromellose USP 2% w/v

Purpose

Lubricant

Medication Information

Purpose

Lubricant

Description

Hypromellose USP 2% w/v

Use

For use as a lubricant to prevent further irritation or to relieve dryness of the eye

Dose

Instill 1 or 2 drops in the affected eyes as needed

Stop Use
  • Transient blurring of vision
  • Ocular discomfort or irritation
  • Matting or Stickness of eyelashes
  • Photophobia
  • Hypersensitivity or edema of the eyelids
Warnings

For External use only

Questions

Call. 1-800-103-7321,

E-mail : [email protected]

Web : www.aurolab.com

Do Not Use
  • If the solution becomes dark brown or any floating particles are observed.
  • If you are sensitive to any ingredient in this product
Package Carton

Active Ingredient

Hypromellose USP 2% w/v

Inactive Ingredient
  • Acetic acid 1%
  • Calcium chloride
  • Citric acid 0.1465%
  • Magnesium Chloride
  • Sodium chloride
  • Sodium acetate,
  • Sodium Citrate
  • Potassium chloride
  • Purified water.
Indiacations and Usage

Do not use if package is damaged

Discard after a single use

Do not freeze

Do not resterilize

Keep Out of Reach of Children

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

Structured Label Content

Use (USE)

For use as a lubricant to prevent further irritation or to relieve dryness of the eye

Dose

Instill 1 or 2 drops in the affected eyes as needed

Purpose

Lubricant

Stop Use (STOP USE)
  • Transient blurring of vision
  • Ocular discomfort or irritation
  • Matting or Stickness of eyelashes
  • Photophobia
  • Hypersensitivity or edema of the eyelids
Warnings (WARNINGS)

For External use only

Questions (QUESTIONS)

Call. 1-800-103-7321,

E-mail : [email protected]

Web : www.aurolab.com

Do Not Use (DO NOT USE)
  • If the solution becomes dark brown or any floating particles are observed.
  • If you are sensitive to any ingredient in this product
Package Carton (PACKAGE CARTON)

Active Ingredient (ACTIVE INGREDIENT)

Hypromellose USP 2% w/v

Inactive Ingredient (INACTIVE INGREDIENT)
  • Acetic acid 1%
  • Calcium chloride
  • Citric acid 0.1465%
  • Magnesium Chloride
  • Sodium chloride
  • Sodium acetate,
  • Sodium Citrate
  • Potassium chloride
  • Purified water.
Indiacations and Usage (INDIACATIONS AND USAGE)

Do not use if package is damaged

Discard after a single use

Do not freeze

Do not resterilize

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:23.535926 · Updated: 2026-03-14T23:12:36.957432