FDA.reportPublic FDA data

ZINC-OXYDE PLUS

Manufacturer
Randob Labs,Ltd. DBA Crossingwell Consumer Health
Effective date
2022-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:04:08

Label at a glance#

ProductZINC-OXYDE PLUS
Active ingredientZinc Oxide, FERRIC OXIDE RED
Label structure8 sections

Indications and uses

Helps treat and prevent diaper rash Protects minor skin irritation due to diaper rash and helps protect from wetness Dries the oozing an weeping of poison ivy, oak, or sumac

Dosage and administration

Apply ointment liberally as often as necessary For the treatment of diaper rash, change wet and soiled diapers promptly Cleanse the diaper area, and allow to dry Apply with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Zinc Oxide 20.6%Skin Protectant
Calamine 2.0%Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash

  • Protects minor skin irritation due to diaper rash and helps protect from wetness
  • Dries the oozing an weeping of poison ivy, oak, or sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply ointment liberally as often as necessary
  • For the treatment of diaper rash, change wet and soiled diapers promptly
  • Cleanse the diaper area, and allow to dry
  • Apply with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, cetyl esters, glycerin, glycerol monostearate, lanolin, menthol, PEG-40 hydrogenated castor oil, phenol, sodium bicarbonate, thymol, white petrolatum

SPL UNCLASSIFIED SECTION

Dist. by
CROSSINGWELL
consumer health
Box 440
Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skin Irritation Relief

ZINC-OXYDE
PLUS®
Zinc Oxide (skin protectant) Calamine (skin protectant)

WITH CALAMINE
MULTI PURPOSE OINTMENT

NET WT. 2 OZ. (57 g)

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton
PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52412-77552412-775-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
FERRIC OXIDE RED1K09F3G675ACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ESTERS WAXD072FFP9GUIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LANOLIN7EV65EAW6HIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
PHENOL339NCG44TVIACT
SODIUM BICARBONATE8MDF5V39QOIACT
THYMOL3J50XA376EIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

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
0412afd6-c575-44ec-b40b-a1da2bffb5e23d0233ac-57da-4c63-8922-00517ccb799c2022-04-06WarningsExact identifier
spl id: 0412afd6-c575-44ec-b40b-a1da2bffb5e2
spl set id: 3d0233ac-57da-4c63-8922-00517ccb799c

Reported adverse events (FAERS/openFDA)#

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