Label: ZINCTRAL- zinc oxide paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 15, 2024

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  • 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

    Label

  • INGREDIENTS AND APPEARANCE
    ZINCTRAL 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-627
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GINGER (UNII: C5529G5JPQ)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-627-0557 g in 1 TUBE; Type 0: Not a Combination Product03/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/24/2023
    Labeler - PureTek Corporation (785961046)
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