Otc - Active Ingredient
Carboxymethylcellulose sodium 0.5%
Lubricant Eye Drops
FDA Label NDC 42961-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product Lubricant Eye Drops (NDC 42961-400). 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, indications & usage, otc - keep out of reach of children, dosage & administration, inactive ingredient, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Eye Lubricant
Indications & Usage
- for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
- may be used as a protectant against further irritation
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Dosage & Administration
Directions
- To open, pull and twist tab to remove
- Instill 1 or 2 drops in the affected eye(s) as needed and discard container
- If used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor's instructions
Inactive Ingredient
Calcium Chloride, **Hydrochloric acid, Magnesium Chloride, Potassium Chloride, Purified water, Sodium Chloride, **Sodium Hydroxide, Sodium Lactate. **May contain these ingredients to adjust pH.
Warnings
Warnings
For external use only
Do not use this product if:
- solution changes color or becomes cloudy
- do not reuse
- once opened, discard
- to avoid contamination, do not touch tip of container to any surface
- do not touch unit-dose to eye
- you experience eye pain
- changes in vision occur
- redness or irritation of the eye continues
- redness or irritation of the eye gets worse or lasts more than 72 hours
When using this product
Stop use and ask a doctor if you experience any of the following
* Please review the disclaimer below.
