Drugplain

Stye 319 mg/g

Mineral Oil and Petrolatum · GEL · Insight Pharmaceuticals LLC

7 Recalls on Record
Plain English

Stye is a gel containing mineral oil and petrolatum at 319 mg/g, taken ophthalmic. Manufactured by Insight Pharmaceuticals LLC.

Key Facts

Brand Name
Stye
Generic Name
Mineral Oil and Petrolatum
NDC Code (Product)
63736-238
Manufacturer
Insight Pharmaceuticals LLC
Strength
319 mg/g
Dosage Form
GEL
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
06/15/2010

Recall History

7 Recalls on Record
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II09/01/2023

AMMAN PHARMACEUTICAL INDUSTRIES

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II01/30/2024

Brassica Pharma Pvt Ltd

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue2,776 reports
nausea2,426 reports
diarrhoea2,239 reports
drug ineffective2,104 reports
headache2,049 reports
pain1,901 reports
dizziness1,796 reports
dyspnoea1,723 reports
arthralgia1,643 reports
asthenia1,525 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses* According to homeopathic indications these ingredients provide temporary relief from eye irritation after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Dosage & Administration

Directions Suitable for adults and children ages 5 and over. Dissolve entire tablet under tongue. Do not chew or swallow whole. Take 1 tablet 3 times a day or as directed by a physician. Use up to 6 times a day as needed. Take at least 10 minutes before or at least 10 minutes after eating or drinking. Children under the age of 5: Consult a physician before use.

Warnings

Warnings: A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. This product is intended to complement, not replace, standard medical treatment. Initial worsening of symptoms may occur. This product is intended to be taken orally. Do not use in eyes or nose .

Frequently Asked Questions

What is Stye used for?

Stye contains Mineral Oil and Petrolatum. It is a gel taken ophthalmic. Consult your doctor for specific uses.

Is Stye a controlled substance?

Stye is not classified as a controlled substance by the DEA.

What is the generic name for Stye?

The generic name for Stye is Mineral Oil and Petrolatum. There are 1 other brand versions of Mineral Oil and Petrolatum.

What is the NDC code for Stye 319 mg/g?

The NDC (National Drug Code) for Stye 319 mg/g is 63736-238, listed by Insight Pharmaceuticals LLC.

Product NDC

63736-238

Package NDC

63736-238-24

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)