Otc - Active Ingredient
Active ingredients Purpose
Polyethylene Glycol 400 0.4%...........Eye lubricant
Propylene Glycol 0.3%.......................Eye lubricant
Quality Choice Lubricant
FDA Label NDC 83324-310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Quality Choice Lubricant (NDC 83324-310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- for temporary relief of burning and irritation due to:
- dryness of the eyes
- exposure to wind or sun
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- if this product changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
Otc - When Using
When using this product
- remove contact lenses before using
- replace cap after each use
- do not touch tip of bottle to any surface to avoid contamination
Otc - Stop Use
Stop use and ask a doctor if
- you experience eye pain and/or vision change
- you continue to have eye redness and/or irritation
- irritation, burning persists or worsens for more than 72 hours
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
- shake well before using
- istill 1 or 2 drops in the affected eye(s) as needed
- children under 6 years of age: ask a doctor
Storage And Handling
Other information
- store at room temperature 15-25°C (59-77°F)
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, boric acid, hydrochloric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hydroxide
Dosage & Administration
Distributed by CDMA, Inc.
Novi, MI 48375
Made in South Korea
Package Label.Principal Display Panel
99930 (99930.1)
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