ZINC OXIDE OINTMENT [GERI-GENTLE CORPORATION]

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ZINC OXIDE OINTMENT [GERI-GENTLE CORPORATION]
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NDC 69771-109-38, 69771-109-39
Set ID f5cfab62-8aab-4109-b15b-4fe380f7cb9e
Category HUMAN OTC DRUG LABEL
Packager Geri-Gentle Corporation
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide (20%w/w)

  • 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

    • do not get into eyes
    • do not use over large area of the body

    Stop Use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again in a few days
    • if you are allergic to any of these ingredients

    Do not use on

    • deep puncture wounds
    • animal bites
    • serious burns

    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 diaper promptly
    • cleanse the diaper area and allow to dry
    • apply as needed
  • Other information

    • store at 59°-86°F (15°-30°C)
    • avoid excessive heat
  • Inactive Ingredients

    Cetostearyl Alcohol, Cetomacrogol 1000, Lanolin, Light Liquid Paraffin, White Soft Paraffin

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Box

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-109
    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
    LANOLIN (UNII: 7EV65EAW6H)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-109-381 in 1 BOX01/15/2017
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69771-109-391 in 1 BOX01/15/2017
    256.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/15/2017
    Labeler - Geri-Gentle Corporation (080367686)
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