Drugplain

Diaper Rash 400 mg/g

Zinc oxide · OINTMENT · WinCo Foods, LLC

3 Recalls on Record
Plain English

Diaper Rash is a ointment containing zinc oxide at 400 mg/g, taken topical. Manufactured by WinCo Foods, LLC.

Key Facts

Brand Name
Diaper Rash
Generic Name
Zinc oxide
NDC Code (Product)
67091-020
Manufacturer
WinCo Foods, LLC
Strength
400 mg/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
08/01/2022

Recall History

3 Recalls on Record
Class II11/10/2011

Victus, Inc.

Misbranded

TerminatedVoluntary: Firm initiated
Class III02/21/2017

Bayer HealthCare Pharmaceuticals, Inc.

Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.

TerminatedVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective529 reports
macular degeneration454 reports
off label use334 reports
pyrexia322 reports
nausea307 reports
pain297 reports
malaise267 reports
weight decreased242 reports
therapeutic product effect incomplete214 reports
headache213 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Dosage & Administration

Directions change wet and soiled diapers promptly cleanse the diaper area allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Warnings

Warnings For external use only

Adverse Reactions

Adverse Reactions DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908 USA 855-423-2630

Frequently Asked Questions

What is Diaper Rash used for?

Diaper Rash contains Zinc oxide. It is a ointment taken topical. Consult your doctor for specific uses.

Is Diaper Rash a controlled substance?

Diaper Rash is not classified as a controlled substance by the DEA.

What is the generic name for Diaper Rash?

The generic name for Diaper Rash is Zinc oxide. There are 12 other brand versions of Zinc oxide.

What is the NDC code for Diaper Rash 400 mg/g?

The NDC (National Drug Code) for Diaper Rash 400 mg/g is 67091-020, listed by WinCo Foods, LLC.