Label: RUGBY ZINC OXIDE- zinc oxide ointment

  • NDC Code(s): 0536-5700-25, 0536-5700-28, 0536-5700-98
  • Packager: Rugby Laboratories
  • 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 January 13, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc oxide 20%

  • Purpose

    Skin Protectant

  • 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.
  • 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.

  • 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
  • Inactive ingredients

    mineral oil, petrolatum

  • 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

  • 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)

    Principal Display Panel – Jar Label

  • Principal Display Panel - 30 g Tube

    Rugby Zinc Oxide Ointment USP

    Skin protectant Zinc Oxide 20%

    Help Soothe & Protect Chafed Skin

    NET WT 30G (1.05oz)

    Principal Display Panel - 30 g Tube

  • Principal Display Panel - 30 g Carton

    Rugby Zinc Oxide Ointment USP

    Skin protectant Zinc Oxide 20%

    Help Soothe & Protect Chafed Skin

    NET WT 30G (1.05oz)

    Principal Display Panel - 30 g Carton

  • INGREDIENTS AND APPEARANCE
    RUGBY ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-5700-98454 g in 1 JAR; Type 0: Not a Combination Product03/23/2004
    2NDC:0536-5700-281 in 1 CARTON09/24/2018
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0536-5700-251 in 1 CARTON09/06/2018
    360 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/23/2004
    Labeler - Rugby Laboratories (079246066)
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