RUGBY ZINC OXIDE (ZINC OXIDE) OINTMENT [RUGBY LABORATORIES]

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RUGBY ZINC OXIDE (ZINC OXIDE) OINTMENT [RUGBY LABORATORIES]
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NDC 0536-5700-25, 0536-5700-28, 0536-5700-98
Set ID 2f70f5e3-6b1f-4848-8031-c686ee2d8cc3
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART347
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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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