FDA Label for Zinctral

View Indications, Usage & Precautions

Zinctral Product Label

The following document was submitted to the FDA by the labeler of this product Puretek Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.