Ultra 3 mg/mL
Chloroxylenol 0.3% · LIQUID · Old East Main Co.
Ultra is a liquid containing chloroxylenol 0.3% at 3 mg/mL, taken topical. Manufactured by Old East Main Co..
Key Facts
- Brand Name
- Ultra
- Generic Name
- Chloroxylenol 0.3%
- NDC Code (Product)
55910-589- Manufacturer
- Old East Main Co.
- Strength
- 3 mg/mL
- Dosage Form
- LIQUID
- Route
- TOPICAL
- Marketing Status
- Application #
- 505G(a)(3)
- Marketing Start
- 01/17/2017
Recall History
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Lack of Assurance of Sterility
Johnson & Johnson Consumer, Inc.
cGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses For the relief of pressure and bloating commonly referred to as gas
Dosage & Administration
Directions adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Warnings
Warnings If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
Frequently Asked Questions
What is Ultra used for?
Ultra contains Chloroxylenol 0.3%. It is a liquid taken topical. Consult your doctor for specific uses.
Is Ultra a controlled substance?
Ultra is not classified as a controlled substance by the DEA.
What is the generic name for Ultra?
The generic name for Ultra is Chloroxylenol 0.3%. There are no other listed brand versions of Chloroxylenol 0.3%.
What is the NDC code for Ultra 3 mg/mL?
The NDC (National Drug Code) for Ultra 3 mg/mL is 55910-589, listed by Old East Main Co..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)