ZINC OXIDE OINTMENT [RITEAID]

ZINC OXIDE OINTMENT [RITEAID]
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NDC 11822-0081-3
Set ID 8a3421c6-8533-4e93-b31d-f497fe33c80b
Category HUMAN OTC DRUG LABEL
Packager RiteAid
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT


    Active ingredient                      Purpose


    Zinc Oxide........................................Skin protectant
  • PURPOSE


    Active ingredient                 Purpose

    Zinc Oxide.................................Skin protectant

    Uses

    - dries the oozing and weeping od poison - ivy - oak - sumac
    - helps treat and prevent diaper rash
    - protects chafed skin associated with diaper rash and helps protect from wetness

  • KEEP OUT OF REACH OF CHILDREN


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


    Uses

    - dries the oozing and weeping od poison - ivy - oak - sumac
    - helps treat and prevent diaper rash
    - protects chafed skin associated with diaper rash and helps protect from wetness
  • WARNINGS

    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 the reach of children. If swallowed get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION


    Directions

    - apply as needed

    For diaper rash
    - change wet and soiled diapers promptly
    - cleanse the diaper area, and allow to dry
    - apply liberally as often as necessary, with each diaper change,
    especially at bedtime or anytime when exposure to wet diapers may be prolonged

    - children under 12 years

    ask a doctor

    Other information

    Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

  • INACTIVE INGREDIENT


    Inactive Ingredients

    beeswax, mineral oil, petrolatum

  • PRINCIPAL DISPLAY PANEL

    c
  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0081
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0081-357 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/19/2009
    Labeler - RiteAid (014578892)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture

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