Other
Drug Facts
Distributed by
Sproose Products Inc.
West Hollywood, CA
Hydrate Lubricant
FDA Label NDC 83716-6000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sproose Products Inc. for the product Hydrate Lubricant (NDC 83716-6000). 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 other, otc - purpose, uses, warnings, do not use, when using this product, otc - stop use, 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
| Active Ingredients | Purposes |
|---|---|
| Polyethylene glycol 400 0.04% | Lubricant |
| Propylene glycol 0.3% | Lubricant |
Uses
- for the temporary relief of burning and irritation due to dryness of the eye
Warnings
For external use only
Do Not Use
- if this product changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
When Using This Product
- to avoid contamination do not touch tip of container to any surface
- replace cap after each use
- remove contacts before using
Otc - Stop Use
Stop use and ask a doctor if you experience any of the following
- eye pain
- changes in vision
- continued redness or irritation of the eye
- the condition worsens or persists for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- shake well before using
- Instill 1 or 2 drops in the affected eye(s) as needed
Other Information
store at 15°-30°C (59°-86°F)
Inactive Ingredients
Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Questions?
866-778-0043 Alchemy43.com
Principal Display Panel - 15 Ml Bottle Carton
ALCHEMY 43
HYDRATE
LUBRICANT
EYE DROPS
STERILE 0.5 FL. OZ (15mL)
Principal Display Panel (15 mL Bottle Carton)
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