Drugplain

Skin Protectant 25 mg/100mg

Zinc Oxide 25% · OINTMENT · Cardinal Health

10 Recalls on Record
Plain English

Skin Protectant is a ointment containing zinc oxide 25% at 25 mg/100mg, taken topical. Manufactured by Cardinal Health.

Key Facts

Brand Name
Skin Protectant
Generic Name
Zinc Oxide 25%
NDC Code (Product)
70000-0488
Manufacturer
Cardinal Health
Strength
25 mg/100mg
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
01/16/2019

Recall History

10 Recalls on Record
Class II08/27/2025

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

OngoingVoluntary: Firm initiated
Class III01/07/2020

Sigan Industries Inc.

Microbial contamination of non-sterile product.

TerminatedVoluntary: Firm initiated
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated
Class II06/08/2017

Phillips Co.

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

TerminatedVoluntary: Firm initiated
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated
Class II06/08/2017

Phillips Co.

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

TerminatedVoluntary: Firm initiated
Class II12/28/2017

DLC Laboratories, Inc

Microbial Contamination of Non-Sterile Products.

TerminatedVoluntary: Firm initiated
Class II06/08/2017

Phillips Co.

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

TerminatedVoluntary: Firm initiated
Class II08/27/2025

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

OngoingVoluntary: Firm initiated
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective904 reports
off label use703 reports
macular degeneration663 reports
constipation650 reports
nausea624 reports
pain582 reports
pyrexia563 reports
abdominal pain460 reports
anaemia437 reports
vomiting431 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak or sumac insect bites

Dosage & Administration

Directions Apply as needed

Warnings

Warnings For external use only. 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.

Frequently Asked Questions

What is Skin Protectant used for?

Skin Protectant contains Zinc Oxide 25%. It is a ointment taken topical. Consult your doctor for specific uses.

Is Skin Protectant a controlled substance?

Skin Protectant is not classified as a controlled substance by the DEA.

What is the generic name for Skin Protectant?

The generic name for Skin Protectant is Zinc Oxide 25%. There are no other listed brand versions of Zinc Oxide 25%.

What is the NDC code for Skin Protectant 25 mg/100mg?

The NDC (National Drug Code) for Skin Protectant 25 mg/100mg is 70000-0488, listed by Cardinal Health.

Product NDC

70000-0488

Package NDC

70000-0488-1

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

Data from openFDA · Public domain (CC0 1.0)