ZINC OXIDE OINTMENT [DELSAM PHARMA LLC]

ZINC OXIDE OINTMENT [DELSAM PHARMA LLC]
PDF | XML

NDC 72570-109-30
Set ID a66aa9ff-5c1d-4f8d-982e-2d6f6e130195
Category HUMAN OTC DRUG LABEL
Packager Delsam Pharma Llc
Generic Name
Product Class
Product Number
Application Number PART347
  • Drug Facts

  • Active ingredient

    Zinc oxide USP 20%

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash  • dries the oozing and weeping of:  • poison ivy  • poison oak  • poison sumac

  • Warnings

    For external use only

    When using this product  • avoid contact with eyes

    Stop use and ask a doctor if  • conditions worsens  • symptoms last more than 7 days or clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For diaper rash

    • change wet and soiled diapers promptly, allow to dry

    • apply ointment liberally with each diaper change especially at bedtime or anytime when exposure to wet diapers may be prolonged

    To dry the oozing and weeping of poison ivy, poison oak, or poison sumac

    • apply ointment liberally as often as needed.

  • Inactive ingredients

    Mineral Oil, White Petroleum Jelly

  • Other information

    • do not use if seal is punctured or is not visible  • use cap to puncture seal  • store at room temperature  • do not exceed 30°C (86°F)

  • Questions or comments?

    1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Delsam Pharma Llc

    Bronx, Newyork 10467.

  • Packaging

    Zinc109

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72570-109-301 in 1 CARTON09/25/2018
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/25/2018
    Labeler - Delsam Pharma Llc (081369679)

Related Drugs