Label: ZINC-OXYDE PLUS- zinc oxide and ferric oxide red cream

  • NDC Code(s): 52412-775-02
  • Packager: Randob Labs,Ltd. DBA Crossingwell Consumer Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 6, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

    For external use only

    When using this product

    • avoid contact with 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 children. In case of accidental ingestion contact a physician or Poison Control Center immediately.

  • Directions

    • 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

    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

    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
  • INGREDIENTS AND APPEARANCE
    ZINC-OXYDE PLUS 
    zinc oxide and ferric oxide red cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-775
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.206 g  in 1 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    THYMOL (UNII: 3J50XA376E)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Product Characteristics
    ColorPINK (White to light pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-775-0257 g in 1 TUBE; Type 0: Not a Combination Product03/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34703/30/2022
    Labeler - Randob Labs,Ltd. DBA Crossingwell Consumer Health (061995007)
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