FDA.reportPublic FDA data

Zinc Oxide Ointment

Manufacturer
Galentic Pharma (India) Private Limited
Effective date
2022-11-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:46:19

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

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

Storage and handling

Store at 15° to 30° C (59° to 86° F) Lot No. & Exp. Date: See box or crimp of tube

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

• ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

• PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

• USES

INDICATIONS & USAGE SECTION

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.

OTC - WHEN USING SECTION

  • When using this product
    • do not get into eyes

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

• DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly
  • Cleanse 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

• OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Store at 15° to 30° C (59° to 86° F)
  • Lot No. & Exp. Date: See box or crimp of tube

• INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin

SPL UNCLASSIFIED SECTION

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

Gandhidham-370 230, Gujarat. India

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Galentic

Zinc Oxide
Ointment
SKIN PROTECTANT

Helps Heal, Soothe &
Prevent Diaper Rash

NET WT.
1 OZ. (28g)

Principal Display Panel - 28 g Tube Carton
Principal Display Panel - 28 g Tube Carton

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
50382-05150382-051-13, 50382-051-14, 50382-051-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT
CHLOROCRESOL36W53O7109IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
ZINC OXIDESOI2LOH54ZACTIB

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
ee828336-d292-2eb6-e053-2995a90ad9db45e1d7b2-934c-4de0-a16e-01ecd1c0619e2022-11-28WarningsExact identifier
spl id: ee828336-d292-2eb6-e053-2995a90ad9db
spl set id: 45e1d7b2-934c-4de0-a16e-01ecd1c0619e

Reported adverse events (FAERS/openFDA)#

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