Drugplain

Empower 30 g/100g

White Petrolatum, Zinc Oxide · SPRAY · Bemis Manufacturing Company Inc

4 Recalls on Record
Plain English

Empower is a topical spray containing white petrolatum and zinc oxide that is used to protect and soothe skin irritation, diaper rash, and minor wounds. This over-the-counter product creates a moisture barrier on the skin to help prevent further irritation and promote healing.

Key Facts

Brand Name
Empower
Generic Name
White Petrolatum, Zinc Oxide
NDC Code (Product)
83744-001
Manufacturer
Bemis Manufacturing Company Inc
Strength
30 g/100g
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
10/18/2023

Recall History

4 Recalls on Record
Class II05/12/2023

Empower Clinic Services LLC dba Empower Pharmacy

Mislabeling: preservative free product labeled as preserved.

CompletedVoluntary: Firm initiated
Class II08/02/2024

EMPOWER CLINIC SERVICES LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/02/2025

Empower Clinic Services, LLC dba Empower Pharmacy

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II09/05/2024

Empower Pharmacy

Lack of Assurance of Sterility

Terminated

Side Effects Reported to FDA

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

nausea21 reports
vomiting17 reports
fatigue16 reports
off label use16 reports
back pain14 reports
sepsis14 reports
pain13 reports
rash12 reports
dyspnoea11 reports
weight decreased11 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Helps treat and prevent rashes Protects chafed skin from wetness

Dosage & Administration

Directions Cleanse and dry the affected area Spray 4-6" from the skin and allow time to dry Apply as needed

Warnings

Warnings Flammable For external use only 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 clears up and occur again within a few days Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Empower used for?

Empower is a topical spray containing white petrolatum and zinc oxide that is used to protect and soothe skin irritation, diaper rash, and minor wounds. This over-the-counter product creates a moisture barrier on the skin to help prevent further irritation and promote healing.

Is Empower a controlled substance?

Empower is not classified as a controlled substance by the DEA.

What is the generic name for Empower?

The generic name for Empower is White Petrolatum, Zinc Oxide. There are 4 other brand versions of White Petrolatum, Zinc Oxide.

What is the NDC code for Empower 30 g/100g?

The NDC (National Drug Code) for Empower 30 g/100g is 83744-001, listed by Bemis Manufacturing Company Inc.

Product NDC

83744-001

Package NDC

83744-001-40

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)