Drugplain

Powder 1.75 mg/100mg

Titanium Dioxide · POWDER · Oxygen Development LLC

10 Recalls on Record
Plain English

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

10 Recalls on Record
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II09/05/2012

F. Hoffmann-LaRoche Ltd.

Lack of Assurance of Sterility; container closure issues with the bulk batch.

TerminatedVoluntary: Firm initiated
Class III07/22/2022

Teva Pharmaceuticals USA Inc

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

TerminatedVoluntary: Firm initiated
Class II11/09/2015

Freedom Pharmaceuticals Inc

Presence of Foreign Substance

TerminatedVoluntary: Firm initiated
Class II09/10/2018

Pharm D Solutions, LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II12/11/2023

Fagron, Inc

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

OngoingVoluntary: Firm initiated
Class II11/14/2014

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.

TerminatedVoluntary: Firm initiated
Class II09/10/2018

Pharm D Solutions, LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class I08/17/2020

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.

TerminatedVoluntary: Firm initiated
Class I06/20/2018

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective1,388 reports
off label use1,078 reports
pain1,009 reports
headache809 reports
nausea798 reports
pyrexia790 reports
constipation760 reports
macular degeneration662 reports
dyspnoea613 reports
vomiting581 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.