Label: SENIOR B- skin protectant 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 September 3, 2013

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  • PRINCIPAL DISPLAY PANEL

    box image

  • ACTIVE INGREDIENT

    Active Ingredients

    Zinc Acetate 0.2%

  • PURPOSE

    Uses

    Helps treat and prevent pad rash

    Protects from minor skin irritation associated with undergarment rash caused from wetness, urine and/or stool.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • INDICATIONS & USAGE

    Helps prevent skin rashes caused by Incontinence.

  • WARNINGS

    Warnings For external use only

    Do not use On an area that is infected and/or bleeding

    Chafing due to deep puncture wounds, animal bites and/or serious burns

    When using this product Keep out of eyes and mouth

    Stop use an ask a doctor if Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness,

    Irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor

  • DOSAGE & ADMINISTRATION

    Directions

    Clean the area; allow to dry

    Shake well before use

    apply cream liberally to areas as needed

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Aluminum Chlorohydrate, Mineral Oil, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, PEG-40 Stearate, Lanolin, Sorbitan Stearate, Diazolidinyl Urea, Methyl Paraben

  • INGREDIENTS AND APPEARANCE
    SENIOR B 
    skin protectant cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59305-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1.5 g  in 75 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59305-028-021 in 1 BOX
    1NDC:59305-028-0175 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/10/2013
    Labeler - NEAT FEAT PRODUCTS (199291597)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEAT FEAT PRODUCTS199291597manufacture(59305-028)
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