Label: RUGBY ZINC OXIDE- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Zinc oxide 20%

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  • Purpose

    Skin Protectant

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  • Uses

    • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
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  • Warnings

    For external use only

    When using this product, avoid contact with the eyes

    Stop use and ask a doctor if condition worsens or does not improve within 7 days

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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  • Directions

    • apply liberally as often as necessary

    For diaper rash:

    • change wet or soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged
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  • Inactive ingredients

    mineral oil, petrolatum

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  • Questions or comments?

    Call 1-800-645-2158 9 am - 5 pm EST, Monday – Friday

    Store at room temperature 15° - 30°C (59° - 86°F).

    R0507

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Jar Label

    Rugby® NDC 0536-5700-98
    SKIN PROTECTANT

    Zinc Oxide
    Ointment USP
    provides soothing relief from poison ivy,
    oak and sumac
    Treats and prevents diaper rash

    Net Wt 1 lb (454 g)

    Mfd for: Rugby Laboratories, Inc.
    Duluth, Georgia 30097

    Principal Display Panel – Jar Label
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  • INGREDIENTS AND APPEARANCE
    RUGBY ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-5700
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL  
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-5700-98 454 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/23/2004
    Labeler - Rugby Laboratories (191427277)
    Registrant - Faria Limited dba Sheffield Pharmaceuticals (151177797)
    Establishment
    Name Address ID/FEI Business Operations
    Faria LLC dba Sheffield Pharmaceuticals 151177797 MANUFACTURE(0536-5700)
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