Stye Gel
FDA Label NDC 63736-238

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Stye (NDC 63736-238). 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 active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Mineral oil 31.9%

White petrolatum 57.7%

Purpose

Emollient

Emollient

Uses

  • temporarily relieves burning and irritation of the eye
  • as a lubricant to prevent further irritation of the eye

Warnings

For external use only

When Using This Product

  • to avoid contamination do not touch tip of container to any surface
  • replace cap after use

Stop Use And Ask A Doctor If

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens
  • condition persists for more than 72 hours

Keep Out Of Reach Of Children.

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

Directions

  • pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid

Other Information

Do not use if cap neck-seal is cut, broken, or missing.

  • Keep carton for full drug facts.

Inactive Ingredients

microcrystalline wax, stearic acid, wheat germ oil

Questions?

call 1-800-344-7239

Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749

CLINICALLY PROVEN SYMPTOMATIC RELIEF

Temporarily relieves discomfort due to minor irritations including:

  • Burning
  • Stinging
  • Itching

Principal Display Panel

Ophthalmologist
Tested
Stye™
Sterile Lubricant
Eye Ointment
NET WT. 0.125 OZ (3.5g)
SAFETY SEALED CAP

Principal Display Panel Ophthalmologisttestedstye™sterile Lubricanteye Ointmentnet Wt. 0.125 Oz (3.5g)safety Sealed Cap (Stye 01)

Principal Display Panel Ophthalmologisttestedstye™sterile Lubricanteye Ointmentnet Wt. 0.125 Oz (3.5g)safety Sealed Cap (Stye 01)

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