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 October 6, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient                                                  Purpose

    Zinc oxide 13%.................................................. 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

  • ASK DOCTOR

    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, especialy at bedtime or anything when exposure to wet diapers may be prolonged
  • STORAGE AND HANDLING

    Other information

    • Store at 20° to 25°C (68° to 77° F)
    • Lot No & Exp Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients aloe vera leaf, dimethicone, fragrance, magnesium sulfate hydrate, methylparaben, microcrystalline wax, mineral oil, petrolatum, propylene glycol, propylparaben, sodium hydroxide, sorbitan sesquioleate, tocopherol acetate, yellow wax, water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    Amerisource Bergen

    1300 Morris Drive

    Chesterbrook, PA 19087

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-279
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION13 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-279-461 in 1 CARTON10/06/2016
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/23/2014
    Labeler - Amerisource Bergen (007914906)
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