Powder 1.75 mg/100mg
Titanium Dioxide · POWDER · Oxygen Development LLC
Powder is a powder containing titanium dioxide at 1.75 mg/100mg, taken topical. Manufactured by Oxygen Development LLC.
Key Facts
- Brand Name
- Powder
- Generic Name
- Titanium Dioxide
- NDC Code (Product)
61354-119- Manufacturer
- Oxygen Development LLC
- Strength
- 1.75 mg/100mg
- Dosage Form
- POWDER
- Route
- TOPICAL
- Marketing Status
- Application #
- M020
- Marketing Start
- 10/27/2023
Recall History
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
F. Hoffmann-LaRoche Ltd.
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Teva Pharmaceuticals USA Inc
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Freedom Pharmaceuticals Inc
Presence of Foreign Substance
Pharm D Solutions, LLC
Lack of Assurance of Sterility
Fagron, Inc
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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.
Pharm D Solutions, LLC
Lack of Assurance of Sterility
Maison Terre, LLC
Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
Gaia Ethnobotanical LLC
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use Reduces underarm wetness.
Dosage & Administration
Directions Apply to underams only.
Warnings
Warnings For external ues only. Do not use on broken skin. Stop use if rash or irritation occurs Ask a doctor before use if you have kidney disease KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately.
Frequently Asked Questions
What is Powder used for?
Powder contains Titanium Dioxide. It is a powder taken topical. Consult your doctor for specific uses.
Is Powder a controlled substance?
Powder is not classified as a controlled substance by the DEA.
What is the generic name for Powder?
The generic name for Powder is Titanium Dioxide. There are 12 other brand versions of Titanium Dioxide.
What is the NDC code for Powder 1.75 mg/100mg?
The NDC (National Drug Code) for Powder 1.75 mg/100mg is 61354-119, listed by Oxygen Development LLC.
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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)