Label: PREMIER VALUE ZINC OXIDE- 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 April 30, 2013

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  • ACTIVE INGREDIENT

    Active ingredient                                                              Purpose

    Zinc Oxide 20%.............................................................Skin protectant

  • PURPOSE

    Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps protect skin from wetness
    • protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac
    • 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

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

    Inactive ingredients aloe vera gel, liquid paraffin, tocopherol acetate, white beeswax, white petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed By

    Chain Drug Consortium

    3301 NW Boca Raton Blvd. Suite 101

    Boca Raton, FL 33431

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE ZINC OXIDE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-252
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-252-001 in 1 CARTON
    156 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/30/2013
    Labeler - Chain Drug Consortium, LLC (101668460)
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