Walgreens Zinc Oxide
FDA Label NDC 0363-6771

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Zinc Oxide (NDC 0363-6771). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Indications & Usage

→ Storage And Handling

→ Inactive Ingredient

→ Dosage & Administration

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredient Purpose

Zinc oxide 40%.............................................Skin protectant

Otc - Purpose

Uses

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

Warnings

For external use only.

This product contains trace amounts of naturally occurring metals. Do not use on broken skin

Otc - When Using

When using this product

do not get into eyes

Otc - Stop Use

Stop use and ask a doctor if

condition worsens
symtoms last more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions

change wet or soiled diapers promptly
clean 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.