Label: CAREALL ZINC OXIDE- zinc oxide ointment

  • NDC Code(s): 51824-032-03, 51824-032-04, 51824-032-15
  • Packager: New World Imports Inc
  • 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 1, 2021

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

  • ACTIVE INGREDIENT

    Zinc Oxide

  • PURPOSE

    Skin Protectant

  • 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

    • Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips
    • Protects and dries the oozing and weeping of poison ivy, poison oak, and poison sumac
    • Helps treat and prevent diaper rash
    • protecs chafed skin due to diaper rash and helps seal out wetness
  • WARNINGS

    For external use only.

    When using this product avoid contact with eyes

    Stop use and ask a doctor if condition worsens or does not improve within 7 days.  This may be a sign of a serious condition

  • DOSAGE & ADMINISTRATION

    • Apply ointment liberally as often as necessary
    • For the treatment of diaper rash, change wet and soild diapers promptly
    • Cleanse the diaper area and allow to dry
    • Apply with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • INACTIVE INGREDIENT

    Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin

  • PRINCIPAL DISPLAY PANEL

    Zinc Carton

  • INGREDIENTS AND APPEARANCE
    CAREALL ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    Light Mineral Oil (UNII: N6K5787QVP)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-032-15425 g in 1 JAR; Type 0: Not a Combination Product04/04/2013
    2NDC:51824-032-0328 g in 1 TUBE; Type 0: Not a Combination Product04/04/2013
    3NDC:51824-032-0456 g in 1 TUBE; Type 0: Not a Combination Product04/04/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/04/2013
    Labeler - New World Imports Inc (075372276)