FDA.reportPublic FDA data

Zinctral

Manufacturer
PureTek Corporation
Effective date
2024-04-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:36

Label at a glance#

ProductZinctral
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

dries the oozing and weeping of poison: ivy oak sumac Helps treat and prevent diaper rash. Protects minor skin irritations due to diaper rash and helps protect from wetness.

Dosage and administration

Cleanse skin with DiaSinc All Purpose Cleansing Spray and apply paste to area as needed. Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Storage and handling

protect from freezing avoid excessive heat Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.0%

(3.0% as Calamine)

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 minor skin irritations due to diaper rash and helps protect from 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 childern.

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

  • Cleanse skin with DiaSinc All Purpose Cleansing Spray and apply paste to area as needed.
  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product 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

  • protect from freezing
  • avoid excessive heat
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance (Contains: Alpha-Isomethyl Ionone, Butylphenyl Methylpropional, Coumarin, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool), GenRx Complex® [Consisting of: Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, DL-Alpha-Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract ], Petrolatum, Phenoxyethanol, Zea Mays (Corn) Starch.

Zinctral™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:

PureTek Corporation
Panorama City, CA 91402
For questions or information call toll-free: 877-921-7873

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416684zinc oxide 20 % Topical PastePSN2
416684zinc oxide 0.2 MG/MG PasteSCD2
416684zinc oxide 20 % Topical PasteSY2
416684ZNO 0.2 MG/MG PasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-627-05Zinctral57 g in 1 TUBEPASTE572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-627ZINCTRAL (ZINC OXIDE) PASTE [PURETEK CORPORATION]2Current NDC, 1 package rows20241004_de990834-00da-0c7a-e053-2995a90a7c37.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-627-05GM - Gram59088-6279aded5ce-1555-4c4e-9513-b31430f9779a12023-05-05

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-62759088-627-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
LEVOMENOL24WE03BX2TIACT
KUKUI NUT OILTP11QR7B8RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
MALTODEXTRIN7CVR7L4A2DIACT
NIACINAMIDE25X51I8RD4IACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GINGERC5529G5JPQIACT
ZINC OXIDESOI2LOH54ZACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
SAFFLOWER OIL65UEH262ISIACT

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
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
ndc (package): 59088-627-05
ndc (product): 59088-627
ndc11 (package): 59088062705
spl id: 162940b9-62b7-aa7b-e063-6294a90a86c3
spl set id: de990834-00da-0c7a-e053-2995a90a7c37

Reported adverse events (FAERS/openFDA)#

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