DR. SHEFFIELD BARRIER CREAM (BARRIER CREAM) CREAM [SHEFFIELD PHARMACEUTICALS, LLC]

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  • DR. SHEFFIELD BARRIER CREAM (BARRIER CREAM) CREAM [SHEFFIELD PHARMACEUTICALS, LLC]

DR. SHEFFIELD BARRIER CREAM (BARRIER CREAM) CREAM [SHEFFIELD PHARMACEUTICALS, LLC]
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NDC 11527-213-22, 11527-213-75
Set ID de3580fb-e167-4ee7-adc5-fe43ac10ae1d
Category HUMAN OTC DRUG LABEL
Packager Sheffield Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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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 doctorDo not put prodcut 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

    <Adults: When practical ,cleanse the affected areawith a mild soap and warm water and rinse thorughly. Gently dry by pattingor blotting with toilet tissue or a soft cloth beforeapplication of this product.Children under 12 years of age: consult a doctor. Apply extrenally to the affectedarea u pto 6 times a day.>

  • 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 11527-213-22

    Dr. Sheffield's

    Made in the USA

    Dual action Barrier Cream with pain relief

    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 - Packet

    Principal Display Panel - Packet

    NDC # 11527-213-75

    Dr. Sheffield's  Made in the USA

    Dual Action Barrier Cream with Pain Relief 

    0.45% Menthol - External Analgesic

    20% Zinc Oxide -Astrigent 

    • Soothes and protects irritaed or chafed skin associated with incontinence 
    • Temporarily relief of pain & itching

    NET WT 4g( 1/7oz)

  • Principal Display Panel - Carton

    Principal Display Panel - Carton

    NDC# 11527-213-75

    Dr. Sheffield's  Made in the USA

    Dual Action Barrier Cream 

    0.45% Menthol

    20% Zinc Oxide 

    • Soothes and protects irritated or chafed skin associated with incontinence
    • Provided temporary relief of pain & itching
    1 GROSS ( 144pcs.)Net Wt. 4 g (1/7 oz) packets 
  • INGREDIENTS AND APPEARANCE
    DR. SHEFFIELD BARRIER CREAM 
    barrier cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-213
    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:11527-213-22113 g in 1 TUBE; Type 0: Not a Combination Product02/28/2017
    2NDC:11527-213-75144 in 1 BOX05/31/2017
    24.0 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/28/2017
    Labeler - Sheffield Pharmaceuticals, LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals, LLC151177797MANUFACTURE(11527-213)
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