Label: RITE AID DIAPER RASH- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 20, 2010

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  • ACTIVE INGREDIENT


    Active ingredient                            Purpose

    Zinc Oxide. 40%.......................................Skin protectant
  • PURPOSE


    Uses

    - helps treat and prevent diaper rash
    - protects chafed skin due to diaper rash and helps seal out 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

    - helps treat and prevent diaper rash
    - protects chafed skin due to diaper rash and helps seal out 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

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

    Other information

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

  • INACTIVE INGREDIENT


    Inactive Ingredients

    BHA, cod liver oil, fragrance, lanolin, methylparaben, petrolatum, purified water, talc
  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    RITE AID DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0376
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0376-31 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/20/2010
    Labeler - RiteAid Corporation (014578892)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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