Otc - Active Ingredient
Active Ingredient
White Petrolatum USP 91.7%
Light Mineral Oil NF 1.4%
Noveha Nighttime Gel
FDA Label NDC 84008-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bullet Point Llc for the product Noveha Nighttime (NDC 84008-004). 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, inactive ingredient, otc - purpose, warnings, indications & usage, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredient
Lanolin USP 6.9%
Otc - Purpose
Purpose: Active Ingredient
White Petrolatum USP 91.7% . . . . . .Purpose: Eye Protectant
Light Mineral Oil NF 1.4% . . . . . . . . .Purpose: Lubricant
Warnings
Warnings
For use in the eye
Indications & Usage
Uses:
- For temporary relief of burning and irritation due to dryness of the eye.
- For use as a lubricant to prevent further irritation or to relieve dryness of the eye
- Do not touch tip of container to any surface to avoid contamination.
- Replace cap after use
When using this product
Otc - Ask Doctor
Stop use and ask a Doctor if
- Eye pain occurs
- Changes in vision occur
- Redness or irritation persists
- Condition worsens or lasts 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 right away.
Dosage & Administration
Directions
- Pull down the lower lid of the affected eye
- Apply a small amount (about 1⁄4 inch) of ointment inside the eyelid
Other Safety Information
Other Information:
Store at 46°–80°F (8°–27°C)
Do not use if the tamper-evident seal is broken or missing
Otc - Questions
Questions?
* Please review the disclaimer below.
