Drugplain

Diaper Rash Cream 15 g/100g

Zinc Oxide · CREAM · Smalls Brand LLC DBA Roe Wellness

1 Recall on Record
Plain English

Diaper Rash Cream is a cream containing zinc oxide at 15 g/100g, taken topical. Manufactured by Smalls Brand LLC DBA Roe Wellness.

Key Facts

Brand Name
Diaper Rash Cream
Generic Name
Zinc Oxide
NDC Code (Product)
83369-002
Manufacturer
Smalls Brand LLC DBA Roe Wellness
Strength
15 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
02/27/2026

Recall History

1 Recall on Record
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

Side Effects Reported to FDA

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

drug ineffective506 reports
macular degeneration453 reports
off label use313 reports
pyrexia303 reports
nausea284 reports
pain280 reports
malaise259 reports
weight decreased235 reports
therapeutic product effect incomplete213 reports
headache201 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, and allow to dry. Apply product 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. Do not use on • deep or puncture wounds • animal bites • serious burns. When using this product • do not get into eyes. Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use Not intended to cure any medical condition. For external use only If any sensitivity or adverse reaction occurs, discontinue use and see your physician.

Frequently Asked Questions

What is Diaper Rash Cream used for?

Diaper Rash Cream contains Zinc Oxide. It is a cream taken topical. Consult your doctor for specific uses.

Is Diaper Rash Cream a controlled substance?

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

What is the generic name for Diaper Rash Cream?

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

What is the NDC code for Diaper Rash Cream 15 g/100g?

The NDC (National Drug Code) for Diaper Rash Cream 15 g/100g is 83369-002, listed by Smalls Brand LLC DBA Roe Wellness.