Label: DR. SMITHS RASH AND SKIN- 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 April 3, 2013

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  • ACTIVE INGREDIENT

    Drug Facts

    Active IngredientPurpose
    Petrolatum 57%Skin Protectant
    Lanolin 16%Skin Protectant
  • DOSAGE & ADMINISTRATION

  • PURPOSE

    Uses

    temporarily protest minor:

    • cuts
    • scrapes
    • burns
  • INDICATIONS & USAGE

    Temporarily protects and helps relieve chapped, chafed, or cracked skin.

    Helps protect from the dying effects of wind and cold weather.

    Helps treat and prevent rash caused by adult incontinence.

  • WARNINGS

    Warnings

    For external use only.

  • WHEN USING

    When using this product, avoid contact with eyes.

  • ASK DOCTOR

    See a doctor if condition lasts more than 7 days.

  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Directions

    Apply as needed to affected area.

  • QUESTIONS

    Other Information

    Store at 20° – 25°C (68° – 77° F)

  • INACTIVE INGREDIENT

    beeswax, mineral oil, olive oil, paraffin wax, purified water, thymol iodide, zinc oxide.

  • STOP USE

    To report a serious adverse event or obtain product information, call (210) 696-8400



    MISSION PHARMACAL COMPANY
    San Antonio, TX 78230-1355



    51023
    Rev 011120

  • PRINCIPAL DISPLAY PANEL

    Dr Smith’s Rash+Skin Ointment Carton
    NDC: 0178-0370-03

    drs-t25912-1112-dr-smiths-rash-and-skin-3-oz-ctn-fnl-vp2-ew

    drs-t25912-1112-dr-smiths-rash-and-skin-3-oz-ctn-fnl-vp2-ew2
  • INGREDIENTS AND APPEARANCE
    DR. SMITHS RASH AND SKIN 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0370
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U) 57.18 g  in 100 g
    LANOLIN (UNII: 7EV65EAW6H) 16.05 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) 10 g  in 100 g
    MINERAL OIL (UNII: T5L8T28FGP) 6.60 g  in 100 g
    WATER (UNII: 059QF0KO0R) 4.60 g  in 100 g
    WHITE WAX (UNII: 7G1J5DA97F) 2.07 g  in 100 g
    OLIVE OIL (UNII: 6UYK2W1W1E) 2 g  in 100 g
    THYMOL IODIDE (UNII: A51HJM3XSU) 1 g  in 100 g
    PARAFFIN (UNII: I9O0E3H2ZE) .5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0370-031 in 1 CARTON
    1100 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2013
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893MANUFACTURE(0178-0370)
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