Methyl Salicylate 250 mg/g
Methyl Salicylate · CREAM · Alexso, Inc
Methyl Salicylate is a cream containing methyl salicylate at 250 mg/g, taken topical. Manufactured by Alexso, Inc.
Key Facts
- Brand Name
- Methyl Salicylate
- Generic Name
- Methyl Salicylate
- NDC Code (Product)
50488-1015- Manufacturer
- Alexso, Inc
- Strength
- 250 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- M017
- Marketing Start
- 04/01/2019
Recall History
Wuhan Bingbing Pharmaceutical Co., Ltd.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Pharma-Natural Inc.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
KENIL HEALTHCARE PRIVATE LIMITED
CGMP Deviations
Product Quest Manufacturing LLC
Superpotent Drug: high out of specification assay results for the menthol ingredient.
Bonita Pharmaceuticals, LLC
Marketed without an approved NDA/ANDA
Parker Laboratories, Inc.
CGMP Deviations
Vi-Jon, LLC
Incorrect/Undeclared Excipients.
KENIL HEALTHCARE PRIVATE LIMITED
CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED
CGMP Deviations
Vi-Jon, LLC
Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
Full Prescribing Information
Indications & Usage
Use helps control plaque that leads to gingivitis
Dosage & Administration
Directions adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out children under 12 years of age - consult a dentist or doctor this rinse is not intended to replace brushing or flossing
Warnings
Warnings for this product
Adverse Reactions
Adverse Reaction SATISFACTION GUARANTEED Distributed By AmerisourceBergen 1 West First Avenue, Conshohocken, PA 19428 Questions or Concerns? 1-888-593-0593 www.mygnp.com DSP-TN-21091 DSP-MO-20087
Frequently Asked Questions
What is Methyl Salicylate used for?
Methyl Salicylate contains Methyl Salicylate. It is a cream taken topical. Consult your doctor for specific uses.
Is Methyl Salicylate a controlled substance?
Methyl Salicylate is not classified as a controlled substance by the DEA.
What is the generic name for Methyl Salicylate?
The generic name for Methyl Salicylate is Methyl Salicylate. There are 12 other brand versions of Methyl Salicylate.
What is the NDC code for Methyl Salicylate 250 mg/g?
The NDC (National Drug Code) for Methyl Salicylate 250 mg/g is 50488-1015, listed by Alexso, Inc.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)