Label: RUGBY BARRIER CREAM- barrier cream cream

  • 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 May 3, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 0.45%

    Zinc Oxide 20%

  • Purpose

    External Analgesic

    Astringent

  • Uses

    Multipurpose moisture barrier that aids in protecting irritated skin conditions in the perineum, buttocks, lower abdomen and inner thigh due to moisture, occlusion, chafing or continued contact with urine or feces.

    Helps relieve the local itching, discomfort, pain, burning and irritation associated with anorectal disorders and hemorroids.May provide a cooling sensation. 

  • Warnings

    For external use only

    Stop use and consult a doctor 

    •in case of bleeding 

    •if conditions worsenor deos not improve within 7 days

    <Do not exceed recommended daily dosage unless directed by a doctor. Do not put product into rectum by using fingers or any mechanical device or applicatorAllergy Alert:Certain persons can develop allergic reactions to this product. If the symptoms develop or increase,discontinue use and consult a doctor. >

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

  • Other information

    Store at controlled room temperature 20° - 25°C (68° - 77°F)

  • Inactive ingredients

    Calamine, Codliver Oil, Disodium EDTA, Lanolin, Methylparaben, Microcrystalline Wax, Mineral Oil, Petrolatum, Propylparaben, Sodium Borate, Sorbitan Sequioleate, Talc, Water (Purified)

  • Principal Display Panel - Tube Label

    Principal Display Panel - Tube Label

    NDC 0536-1204-73

    Rugby

    Menthol Zinc Ointment

    Anorectal Cream 

    0.45% Menthol -External Analgesic 

    20% Zinc Oxide -Astringent 

    • Protect and soothes irritated or chafed skin associated with incontinence 

    • Temporary relief of pain & itching

    NET WT. 4 oz. (113g)

    Principal Display Panel - Tube Label

    Principal Display Panel - Tube Label
  • Principal Display Panel - Carton

    Principal Display Panel - Carton

    NDC 0536-1204-73

    Rugby

    Menthol Zinc Ointment

    Anorectal Cream  

    0.45% Menthol

    20% Zinc Oxide 

    Net Wt. 4 oz 113 g 

    Principal Display Panel - Carton

  • INGREDIENTS AND APPEARANCE
    RUGBY BARRIER CREAM 
    barrier cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1204
    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
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1204-731 in 1 CARTON05/06/2019
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/03/2019
    Labeler - Rugby Laboratories (079246066)
    Registrant - Sheffield Pharmaceuticals, LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals, LLC151177797MANUFACTURE(0536-1204)
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