Label: RUGBY PETROLATUM HYDRATING SKIN PROTECTANT- petrolatum ointment

  • NDC Code(s): 0536-1143-97, 0536-1143-98
  • Packager: Rugby Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2024

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

View All Sections
  • 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 drugM01605/31/2018
    Labeler - Rugby Laboratories (079246066)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc036464697MANUFACTURE(0536-1143)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!