Zinctral Paste
FDA Label NDC 59088-627

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Zinctral (NDC 59088-627). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of childern., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 20.0%

(3.0% as Calamine)

Purpose

Skin Protectant

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.

Warnings

For external use only

When Using This Product

  • do not get into eyes

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

Keep Out Of Reach Of Childern.

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

Directions

  • 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

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

Inactive Ingredients:

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™

Manufactured in the USA by:

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

* Please review the disclaimer below.