zinc oxide 20%

Manufacturer
Bionpharma Inc | Bionpharma Inc. | Galentic Pharma (India) Private Limited
Effective date
2024-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:14

Label at a glance#

Productzinc oxide 20%
Active ingredientZINC OXIDE
Label structure12 sections

Indications and 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 and administration

■ 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

Storage and handling

■ Store at 15°C – 30°C (59°F – 86°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20 %

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

■ 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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

Other information

STORAGE AND HANDLING SECTION

■ Store at 15°C – 30°C (59°F – 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ceteareth 20, cetostearyl alcohol, light mineral oil, white petrolatum

SPL UNCLASSIFIED SECTION

Manufactured for:
Bionpharma Inc.
Princeton, NJ 08540
MADE IN INDIA

L0000798

KBP0581L-0

R0324
GUJ/DRUGS/G/25/2134

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69452-450-58

• dye-free • paraben-free

• phthalate-free • fragrance-free

a+ health TM

healing ointment

zinc oxide 20% / skin protectant
• protects chafed skin due to diaper rash and helps seal out wetness
• dries the oozing and weeping of poison ivy, oak and sumac

net wt. 15 oz

image001image001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN1
198911zinc oxide 0.2 MG/MG Topical OintmentSCD1
198911zinc oxide 20 % Topical OintmentSY1
198911zinc oxide 200 MG per GM Topical OintmentSY1
198911ZNO 0.2 MG/MG Topical OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-450-58zinc oxide 20%425 g in 1 JAROINTMENT4251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-450ZINC OXIDE 20% OINTMENT [BIONPHARMA INC]1Current NDC, 1 package rows20240420_1549500a-0941-0fba-e063-6394a90a564e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-45069452-450-58

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
ndc (package): 69452-450-58
ndc (product): 69452-450
ndc11 (package): 69452045058
spl id: 1549491b-a7b0-2b4a-e063-6294a90a9196
spl set id: 1549500a-0941-0fba-e063-6394a90a564e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.