RUGBY PETROLATUM HYDRATING SKIN PROTECTANT (PETROLATUM) OINTMENT [RUGBY LABORATORIES]

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RUGBY PETROLATUM HYDRATING SKIN PROTECTANT (PETROLATUM) OINTMENT [RUGBY LABORATORIES]
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NDC 0536-1143-97, 0536-1143-98
Set ID ad63e345-1fe8-4f9a-a32e-8dfcde31bedc
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

    Petrolatum (42%)

  • Purpose

    Skin protectant

  • Uses

    • Temporarily protects and helps relieve chapped or cracked skin and lips.
    • Temporarily protects minor cuts, scrapes, and burns.
    • Helps protect from drying effects of wind and cold weather.
  • Warnings

    For external use only

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    apply as needed.

  • Other information

    Store at room temperature.

  • Inactive ingredients

    ceresin, lanolin alcohol, microcrystalline wax, mineral oil, phenoxyethanol.

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    RUGBY® LABORATORIES
    Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL - 454 g Jar Label

    Rugby®
    NDC 0536-1143-98

    Petrolatum 42%
    Hydrating Ointment

    Skin Protectant

    Deeply hydrates to relieve dry, cracked, or irritated skin

    Free of fragrances

    NET WT 16 OZ (454 g)

    PRINCIPAL DISPLAY PANEL - 454 g Jar Label
  • INGREDIENTS AND APPEARANCE
    RUGBY PETROLATUM HYDRATING  SKIN PROTECTANT
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum420 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ceresin (UNII: Q1LS2UJO3A)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1143-98454 g in 1 JAR; Type 0: Not a Combination Product05/31/2018
    2NDC:0536-1143-97100 g in 1 JAR; Type 0: Not a Combination Product05/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/31/2018
    Labeler - Rugby Laboratories (079246066)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc036464697MANUFACTURE(0536-1143)
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