Label: GOOD NEIGHBOR PHARMACY DIAPER RASH- zinc oxide cream

  • 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 September 20, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                                               Purpose

    Zinc oxide 10% ................................................................Skin protectant

  • PURPOSE

    Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps protect skin from wetness
    • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    over deep or puncture wounds, infections or lacerations

  • WHEN USING

    When using this product

    avoid contact with the eyes

  • STOP USE

    Stop use and ask a doctor

    if condition worsens or does not improve within 7 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.

  • INDICATIONS & USAGE

    Directions

    • change wet and soiled diapers promptly, cleanse the diaper area, and 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
  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • Lot No and Exp Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    White petrolatum, talc, purified lanolin, liquid paraffin, triethanolamine, aloe vera gel, tocoperol acetate, butylated hydroxyloluene, methyl parahydroxybenzoate, purified water

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Amerisource Bergen Corporation

    1300 Morris Drive

    Chesterbrook, PA 19087

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-4058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.10 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    TALC (UNII: 7SEV7J4R1U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68169-4058-21 in 1 CARTON
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/20/2010
    Labeler - TAI GUK PHARM. CO., LTD. (631101656)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAI GUK PHARM. CO., LTD.631101656manufacture