Drugplain

Zinc Oxide 20% .2 g/g

Zinc Oxide · OINTMENT · Pharmacy Value Alliance, LLC

4 Recalls on Record
Plain English

Zinc oxide 20% ointment is a topical skin protectant applied directly to the skin to help treat and prevent diaper rash, minor cuts, scrapes, and other skin irritations. This over-the-counter product creates a protective barrier on the skin to help it heal.

Key Facts

Brand Name
Zinc Oxide 20%
Generic Name
Zinc Oxide
NDC Code (Product)
68016-159
Manufacturer
Pharmacy Value Alliance, LLC
Strength
.2 g/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
07/19/2016

Recall History

4 Recalls on Record
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated
Class II01/08/2025

Johnson, S C and Son, Inc

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

OngoingVoluntary: 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 ■ Dries the oozing and weeping of poison • ivy • oak • sumac ■ Helps treat and prevent diaper rash ■ Protects chafed skin due to diaper rash and helps seal out wetness

Dosage & Administration

Directions ■ For poison ivy, oak & sumac: apply as needed ■ For Diaper Rash Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply ointment liberally as often as necessary, with each diaper change, especially at bed time or anytime when exposure to wet diapers may be prolonged

Warnings

Warnings For external use only

Frequently Asked Questions

What is Zinc Oxide 20% used for?

Zinc oxide 20% ointment is a topical skin protectant applied directly to the skin to help treat and prevent diaper rash, minor cuts, scrapes, and other skin irritations. This over-the-counter product creates a protective barrier on the skin to help it heal.

Is Zinc Oxide 20% a controlled substance?

Zinc Oxide 20% is not classified as a controlled substance by the DEA.

What is the generic name for Zinc Oxide 20%?

The generic name for Zinc Oxide 20% is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for Zinc Oxide 20% .2 g/g?

The NDC (National Drug Code) for Zinc Oxide 20% .2 g/g is 68016-159, listed by Pharmacy Value Alliance, LLC.

Product NDC

68016-159

Package NDC

68016-159-02

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

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