Label: EQUATE 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 August 14, 2017

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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

    Principal Display Panel -Tube

    NDC  49035-156-22

    Equate 

    Dual Action Barrier Cream with Pain Relief 

    Anorectal  Cream 

    Zinc Oxide 20%-Protects and soothes irritated or chafed skin associated with Incontinence

    Menthol 0.45% - Provided Temporary  Relief of Pain & Itching 

     Made in the USA

    NET WT 4 oz ( 113g) 

  • INGREDIENTS AND APPEARANCE
    EQUATE BARRIER CREAM 
    barrier cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-156
    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:49035-156-22113 g in 1 TUBE; Type 0: Not a Combination Product02/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/28/2017
    Labeler - WALMART STORES INC (051957769)
    Registrant - Sheffield Pharmaceuticals, LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals, LLC151177797manufacture(49035-156)
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